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| ID | Type | Description | Link |
|---|---|---|---|
| NCCTG-N0937 | |||
| CDR0000665441 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2011-02016 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.
PRIMARY OBJECTIVES:
I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast cancer patients having a triple negative (estrogen receptor [ER]/progesterone receptor [PR]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.
SECONDARY OBJECTIVES:
I. To describe the confirmed tumor response rate of patients with measurable disease receiving brostallicin and cisplatin.
II. To describe the duration of response in patients with measurable disease receiving brostallicin and cisplatin.
III. To describe the 6-month progression-free survival of patients receiving brostallicin and cisplatin.
IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.
V. To evaluate the adverse event profile of the study regimen (adverse events graded using the Cancer Therapy Evaluation Program [CTEP] Active Version of the Common Terminology Criteria for Adverse Events [CTCAE]).
OUTLINE:
Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cisplatin and brostallicin) | Experimental | Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brostallicin | Drug | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month Progression-free Survival (3-mo PFS) Rate | A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Response Rate | A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
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Inclusion Criteria
Exclusion Criteria
HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified) breast cancer by ASCO/CAP guidelines
Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as > 1% of either receptor by IHC)
Any of the following
Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration
Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the CTCAE)
Major surgery =< 4 weeks prior to registration
Chemotherapy or immunologic therapy =< 3 weeks prior to registration
Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only
* NOTES:
Evidence of active brain metastasis including leptomeningeal involvement
* NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed; to be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued
History of allergy or hypersensitivity to the drugs used in this study (or their excipients) including platinum compounds (cisplatin, carboplatin)
Active, unresolved infection
Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations or co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or would interfere significantly with the proper assessment of safety of the prescribed regimens or would limit compliance with study requirements or would make it undesirable for patient to participate in the trial
Clinically significant cardiovascular or cerebrovascular disease, including any history of the following =< 6 months prior to registration:
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
* NOTE: Patient may not enroll in such clinical trials while participating in this study; exception may be granted for trials related to symptom management (cancer control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD)4 count within institutional normal range and no history of an AIDS-defining illness are eligible
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Moreno Aspitia, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Aurora Presbyterian Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Cisplatin and Brostallicin) | Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin |
| Drug |
Given IV |
|
| Up to 5 years |
| Duration of Response | Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 5 years |
| 6-month Progression-free Survival (6-mo PFS) Rate | 6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | At 6 months |
| Time to Disease Progression | Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | up to 5 years |
| Survival Time | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. | Up to 5 years |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Boulder Community Hospital | Boulder | Colorado | 80301-9019 | United States |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Front Range Cancer Specialists | Fort Collins | Colorado | 80528 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | United States |
| North Suburban Medical Center | Thornton | Colorado | 80229 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii | 96813 | United States |
| Hawaii Medical Center - East | Honolulu | Hawaii | 96817 | United States |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Kauai Medical Clinic | Lihue | Hawaii | 96766 | United States |
| Maui Memorial Medical Center | Wailuku | Hawaii | 96793 | United States |
| Kapiolani Medical Center at Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504 | United States |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Carthage | Carthage | Illinois | 62321 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare - Eureka | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Havana | Havana | Illinois | 62644 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare - Macomb | Macomb | Illinois | 61455 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | 61265 | United States |
| Moline | Illinois | 61265 | United States |
| Illinois CancerCare - Monmouth | Monmouth | Illinois | 61462 | United States |
| OSF Holy Family Medical Center | Monmouth | Illinois | 61462 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Illinois CancerCare - Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois CancerCare - Peru | Peru | Illinois | 61354 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Illinois CancerCare - Princeton | Princeton | Illinois | 61356 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Cancer Center - West Lakes | Clive | Iowa | 50325 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51102 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| Mercy General Health Partners | Muskegon | Michigan | 49443 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Alexandria | Minnesota | 56308 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CentraCare Clinic - River Campus | Saint Cloud | Minnesota | 56303 | United States |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Comprehensive Cancer Care, PC | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59102 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Northern Montana Hospital | Havre | Montana | 59501 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Lakeside Hospital | Omaha | Nebraska | 68130 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Albuquerque | New Mexico | 87110 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45420 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Community Cancer Center | Elyria | Ohio | 44035 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Fisher-Titus Medical Center | Norwalk | Ohio | 44857 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| Southern Ohio Medical Center Cancer Center | Portsmouth | Ohio | 45662 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| United States Air Force Medical Center - Wright-Patterson | Wright-Patterson Air Force Base | Ohio | 45433-5529 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin | 54701 | United States |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | 54548 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | United States |
| Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | 54868 | United States |
| St. Nicholas Hospital | Sheboygan | Wisconsin | 53081 | United States |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Cisplatin and Brostallicin) | Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3-month Progression-free Survival (3-mo PFS) Rate | A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Posted | Number | 95% Confidence Interval | proportion of participants | 3 months |
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| Secondary | Confirmed Response Rate | A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Out of the total number of participants who completed the study and were evaluable for the primary endpoint and adverse events (as provided in the Participant Flow), only a subset of participants (Overall Number of Participants Analyzed specified above) were evaluable for the Confirmed Response Rate. | Posted | Number | 95% Confidence Interval | percentage of confirmed responses | Up to 5 years |
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| Secondary | Duration of Response | Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | 6-month Progression-free Survival (6-mo PFS) Rate | 6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Posted | Number | 95% Confidence Interval | proportion of participants | At 6 months |
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| Secondary | Time to Disease Progression | Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Posted | Median | 95% Confidence Interval | months | up to 5 years |
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| Secondary | Survival Time | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. | Posted | Number | 95% Confidence Interval | months | Up to 5 years |
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|
Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years.
This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Cisplatin and Brostallicin) | Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 29 | 48 | 48 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 9 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 9 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Death NOS | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 9 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9 | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | MedDRA 9 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 9 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 9 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 9 | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | MedDRA 9 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 9 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 9 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | MedDRA 9 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Anal pain | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 9 | Systematic Assessment |
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| Edema limbs | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
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| Fever | General disorders | MedDRA 9 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 9 | Systematic Assessment |
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| General disorders and administration site conditions - Other, specify | General disorders | MedDRA 9 | Systematic Assessment |
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| Infusion related reaction | General disorders | MedDRA 9 | Systematic Assessment |
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| Localized edema | General disorders | MedDRA 9 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 9 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 9 | Systematic Assessment |
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| Pain | General disorders | MedDRA 9 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | MedDRA 9 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
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| Mucosal infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 9 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 9 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| GGT increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Hemoglobin increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 9 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 9 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MedDRA 9 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 9 | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | MedDRA 9 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 9 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Moreno-Aspitia MD | Mayo Clinic | 507-284-1159 | morenoaspitia.alvaro@mayo.edu |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C455279 | brostallicin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Units | Counts |
|---|---|
| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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