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Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006486
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
Detailed Description:

OBJECTIVES:

  • Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.
  • Determine the objective response rate in patients treated with this drug.

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.

  • Arm I: Patients receive oral CAI as above.
  • Arm II: Patients receive a placebo. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Metastatic or unresectable disease
    • Documented disease progression, even after nephrectomy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • The following lesions are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses not confirmed and followed by imaging
      • Cystic lesions

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm3
  • Platelet count at least 75,000/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No baseline neuropathy or cerebellar dysfunction greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior carboxyamidotriazole
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Concurrent epoetin alfa allowed

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006486

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233-1996
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital at North Shore
Manhasset, New York, United States, 11030
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Additional Information:
Publications:
Stadler WM, Rosner G, Small E, Hollis D, Rini B, Zaentz SD, Mahoney J, Ratain MJ. Successful implementation of the randomized discontinuation trial design: an application to the study of the putative antiangiogenic agent carboxyaminoimidazole in renal cell carcinoma--CALGB 69901. J Clin Oncol. 2005 Jun 1;23(16):3726-32. Erratum in: J Clin Oncol. 2005 Jul 20;23(21):4808. Ratain, Mark J [added].
Stadler WM, Rosner G, Rini B, et al.: Successful implementation of the randomized discontinuation trial design (RDTD) with the putative antiangiogenic agent carboxyaminoimidazole (CAI) in renal cell carcinoma (RCC). A Cancer and Leukemia Group B (CALGB) Study. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-773, 2003.

Study ID Numbers: CDR0000068317, CLB-69901
Study First Received: November 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006486     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Carboxyamido-triazole
Calcium Channel Blockers
Urogenital Neoplasms
Cardiovascular Agents
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009