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| ID | Type | Description | Link |
|---|---|---|---|
| E2803 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| paclitaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clinical response |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed collecting duct renal cell carcinoma
Measurable disease
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No more than 2 prior biologic response modifier (BRM) regimens
At least 4 weeks since prior BRM therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| David F. McDermott, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Michael B. Atkins, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States | ||
| Rush-Copley Cancer Care Center |
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| Aurora |
| Illinois |
| 60507 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611 | United States |
| Mercy Hospital and Medical Center | Chicago | Illinois | 60616 | United States |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | United States |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | United States |
| Northwest Medical Specialist, PC | Niles | Illinois | 60714 | United States |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | United States |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | United States |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie | Illinois | 60076 | United States |
| Midwest Cancer Research Group, Incorporated | Skokie | Illinois | 60077 | 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 |
| McFarland Clinic, P. C. | Ames | Iowa | 50010 | United States |
| St. Luke's Hospital | Cedar Rapids | Iowa | 52402 | 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 |
| 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 |
| MeritCare Clinic - Bemidji | Bemidji | Minnesota | 56601 | United States |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | 10466 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Medical Group | Fargo | North Dakota | 58122 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| 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 |
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