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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-4896 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy.
OBJECTIVES: I. Determine the disease free progression at 6 months in patients with locally recurrent or metastatic renal cell cancer (refractory to immunotherapy) treated with carboxyamidotriazole. II. Evaluate the progression free survival rate and response rate in these patients on this regimen. III. Evaluate the toxic effect of this regimen on these patients.
OUTLINE: Patients receive oral carboxyamidotriazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and every 12 months thereafter until death.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboxyamidotriazole | Drug |
DISEASE CHARACTERISTICS: Histologically proven advanced renal cell cancer Locally recurrent or metastatic lesions not amenable to current resection Progressive disease defined as 25% increase from last measurement or new lesions Bidimensionally measurable disease No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and/or SGPT less than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious medical illness or active infection that would preclude chemotherapy compliance No other prior malignancy unless curatively treated and disease free for the past 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy At least 1 (but no more than 2) prior biologic regimen(s) (i.e., interleukin-2, interferon alfa, or combination) and recovered Regimen defined as at least 8 weeks of treatment Prior sargramostim allowed Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy (i.e., megestrol or tamoxifen) and recovered Radiotherapy: No prior radiotherapy to study lesions At least 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy Surgery: Prior nephrectomy allowed Recovered from any recent surgery
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| Name | Affiliation | Role |
|---|---|---|
| David Friedland, MD | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Beckman Research Institute, City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16222691 | Result | Dutcher JP, Leon L, Manola J, Friedland DM, Roth B, Wilding G; Eastern Cooperative Oncology Group. Phase II study of carboxyamidotriazole in patients with advanced renal cell carcinoma refractory to immunotherapy: E4896, an Eastern Cooperative Oncology Group Study. Cancer. 2005 Dec 1;104(11):2392-9. doi: 10.1002/cncr.21473. | |
| Result | Friedland D, Leon L, Manola J, et al.: Carboxyamidotriazole (CAI) in patients with advanced renal cell cancer (RCC) refractory to immunotherapy: an ECOG phase II trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2424, 2002. |
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| Los Angeles |
| California |
| 91010 |
| United States |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5408 | United States |
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | 32608-1197 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5265 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018-1095 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Veterans Affairs Medical Center - Albany | Albany | New York | 12208 | United States |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| Veterans Affairs Medical Center - New York | New York | New York | 10010 | United States |
| Kaplan Cancer Center | New York | New York | 10016 | United States |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center | Cleveland | Ohio | 44195 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| CCOP - Sooner State | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102-1192 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny University | Philadelphia | Pennsylvania | 19146 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57105-1080 | United States |
| MBCCOP - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Veterans Affairs Medical Center - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Pretoria Academic Hospital | Pretoria | 0001 | South Africa |
| 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 |
|---|---|
| C062058 | carboxyamido-triazole |
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