Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: carboxyamidotriazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Carboxyamidotriazole (CAI, NSC #609974) in Patients With Advanced Renal Cell Carcinoma Refractory to Immunotherapy |
| Study Start Date: | March 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, California | |
| Beckman Research Institute, City of Hope | |
| Los Angeles, California, United States, 91010 | |
| Veterans Affairs Medical Center - Palo Alto | |
| Palo Alto, California, United States, 94304 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Inc. | |
| Denver, Colorado, United States, 80209-5031 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| Veterans Affairs Medical Center - Gainsville | |
| Gainesville, Florida, United States, 32608-1197 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Veterans Affairs Medical Center - Brooklyn | |
| Brooklyn, New York, United States, 11209 | |
| Veterans Affairs Medical Center - New York | |
| New York, New York, United States, 10010 | |
| Kaplan Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Veterans Affairs Medical Center - Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| United States, Oklahoma | |
| CCOP - Sooner State | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinical and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Allegheny University | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Veterans Affairs Medical Center - Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Veterans Affairs Medical Center - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| South Africa | |
| Pretoria Academic Hospital | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | David Friedland, MD | University of Pittsburgh |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005045 History of Changes |
| Other Study ID Numbers: | CDR0000067636, ECOG-4896 |
| Study First Received: | April 6, 2000 |
| Last Updated: | December 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Carboxyamido-triazole Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013