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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02705 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000514561 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel + carboplatin | Experimental | Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers. After completion of study treatment, patients are followed periodically for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
| ||
| paclitaxel albumin-stabilized nanoparticle formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate, as Measured by RECIST Criteria | The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable stage IV melanoma
Measurable disease
Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic patients must be willing to submit a repeat biopsy at time of tumor progression)
Brain metastases allowed provided they were previously treated with no progression for ≥ 3 months
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 3 months
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL (may be transfused to meet this requirement)
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 times ULN (elevated bilirubin allowed in patients with documented Gilbert's syndrome)
AST ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after completion of study therapy
No uncontrolled intercurrent illness including, but not limited to, the following:
No peripheral neuropathy ≥ grade 2
No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin previously treated with local resection only or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from prior therapy
At least 4 weeks since prior radiotherapy
At least 4 weeks since prior interferon or interleukin-2
At least 4 weeks since prior chemotherapy (cohort 1 )
No prior chemotherapy in the metastatic setting (cohort 2)
No prior treatment for melanoma with any of the following agents:
No other concurrent chemotherapy
No other concurrent investigational agents
No concurrent radiotherapy, including palliative radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, MD, PhD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21472717 | Result | Kottschade LA, Suman VJ, Amatruda T 3rd, McWilliams RR, Mattar BI, Nikcevich DA, Behrens R, Fitch TR, Jaslowski AJ, Markovic SN. A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group Study, N057E(1). Cancer. 2011 Apr 15;117(8):1704-10. doi: 10.1002/cncr.25659. Epub 2010 Nov 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Prior Chemotherapy, PT) | Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
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| Drug |
|
| Up to 2 years |
| Time to Disease Progression | Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. | Up to 2 years |
| Duration of Response | Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. | Up to 3 years |
| Number of Treatment Cycles Administered | Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. | Up to 2 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | 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 |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| 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 Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | 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 Capitol Hospital | Des Moines | Iowa | 50307 | 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 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | 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, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | 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 | 67042 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | 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 |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | 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 |
| 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 |
| 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 |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Alexandria | Minnesota | 56308 | United States |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | 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 |
| Fergus Falls | Minnesota | 56537 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | 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 |
| Hubert H. 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 |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | 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 |
| Great Falls | Montana | 59405 | 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 |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | 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 |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | 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 |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Broadway | Fargo | North Dakota | 58122 | 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 | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | 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 |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | 54601 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| FG001 | Cohort 2 (Chemotherapy Naive, CN) | For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Prior Chemotherapy, PT) | Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. |
| BG001 | Cohort 2 (Chemotherapy Naive, CN) | For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Tumor Response Rate, as Measured by RECIST Criteria | The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 2 years |
|
|
| |||||||||||||||||||||||||||||
| 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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. | Posted | Median | Full Range | months | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. | Posted | Median | Full Range | months | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. | Participants with Complete or Partial response, were analyzed | Posted | Median | Full Range | months | Up to 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Cycles Administered | Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. | Posted | Median | Full Range | cycles | Up to 2 years |
|
Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration.
This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
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 | Cohort 1 (Prior Chemotherapy, PT) | chemotherapy for their metastatic disease receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. | 3 | 34 | 34 | 34 | ||
| EG001 | Cohort 2 (Chemotherapy Naive, CN) | prior chemotherapy for their metastatic disease, patients receive 100 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. | 5 | 39 | 38 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 9 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 9 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Hearing loss | Ear and labyrinth disorders | MedDRA 9 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 9 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Leukocyte count decreased | 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 loss | 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 |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| 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 |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Neuralgia | 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 |
| |
| Taste alteration | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 9 | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | MedDRA 9 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 9 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 9 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 9 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Svetomir N. Markovic, MD, Ph.D | Mayo Clinic | (507) 284-1370 | markovic.svetomir@mayo.edu |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided
| Male |
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