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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006486 |
RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: carboxyamidotriazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Official Title: | A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).
Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity.
After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients with stable disease are randomized to one of two treatment arms.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
At least 1 unidimensionally measurable lesion
The following lesions are not considered measurable:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000068317, CLB-69901 |
Study First Received: | November 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006486 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Carboxyamido-triazole Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Calcium, Dietary |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Membrane Transport Modulators Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions |