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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E1C99 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
OBJECTIVES:
OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.
Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel plus Carboplatin | Experimental | Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response by RECIST Criteria (Version 1.0) | Number of eligible, treated participants in each response category by RECIST criteria | Assessed every 2 cycles (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria | assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J. Loehrer, MD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States | ||
| Joliet Oncology-Hematology Associates, Limited - West |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004. | ||
| 21502559 | Result | Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. doi: 10.1200/JCO.2010.32.9607. Epub 2011 Apr 18. |
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The study was activated on February 21, 2001 and accrued its first patient on June 19, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thymoma | Patients with diagnosis of thymoma |
| FG001 | Thymic Carcinoma | Patients with diagnosis of thymic carcinoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| paclitaxel | Drug | 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles |
|
|
| Joliet |
| Illinois |
| 60435 |
| United States |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | 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 |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | 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 |
| Meeker County Memorial Hospital | Litchfield | Minnesota | 55355 | 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 |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | 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 |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | 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 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington | New Jersey | 08822 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Aultman Cancer Center at Aultman Hospital | Canton | Ohio | 44710-1799 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Mercy Fitzgerald Hospital | Darby | Pennsylvania | 19023 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Lewistown Hospital | Lewistown | Pennsylvania | 17044 | United States |
| Riddle Memorial Hospital Cancer Center | Media | Pennsylvania | 19063 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton | Pennsylvania | 18510 | United States |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | United States |
| Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center | Upland | Pennsylvania | 19013 | 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 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | 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 |
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | 54868 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thymoma | Patients with diagnosis of thymoma |
| BG001 | Thymic Carcinoma | Patients with diagnosis of thymic carcinoma |
| 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 | Best Overall Response by RECIST Criteria (Version 1.0) | Number of eligible, treated participants in each response category by RECIST criteria | Analysis population included all eligible participants who received at least 1 dose of the protocol treatment | Posted | Number | Participants | Assessed every 2 cycles (6 weeks) |
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|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria | Number of participants achieving a complete or partial response by RECIST criteria | Posted | Median | 95% Confidence Interval | Months | assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter |
|
|
Assessed every 21 days while on treatment and for 30 days after the end of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thymoma | Patients with diagnosis of thymoma | 13 | 24 | 24 | 24 | ||
| EG001 | Thymic Carcinoma | Patients with diagnosis of thymic carcinoma | 14 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac, Other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection with grade 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy - Sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rigors/Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight Gain | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pigmentation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Taste Disturbance | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea w/o Prior Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| AST Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| ALT Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/Lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Memory Loss | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety/Agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy - Motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy - Sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chest Pain | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary Frequency/Urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Male |
|
| Stable Disease |
|
| Progression |
|
| Unevaluable |
|
|