Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006486
First received: November 6, 2000
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor


Condition Intervention Phase
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: carboxyamidotriazole
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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):

Primary Outcome Measures:
  • Proportion of patients progressing on placebo to the proportion progressing on CAI [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Proportions of patients with stable disease [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Objective response [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 335
Study Start Date: October 2000
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (carboxyaminoimidazole)

Patients receive oral 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 receive oral CAI as above.

Drug: carboxyamidotriazole
Given orally
Other Names:
  • CAI
  • carboxyamido-triazole
  • carboxyaminoimidazole
Experimental: Arm II (carboxyamidotriazole, placebo)

Patients receive oral 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 receive a placebo.

Drug: carboxyamidotriazole
Given orally
Other Names:
  • CAI
  • carboxyamido-triazole
  • carboxyaminoimidazole
Other: placebo
Given orally
Other Name: PLCB

Detailed Description:

OBJECTIVES:

I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.

II. 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

Inclusion Criteria:

  • 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
    • 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
  • Performance status - CTC 0-2
  • WBC at least 2,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Creatinine no greater than 2.0 mg/dL
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No baseline neuropathy or cerebellar dysfunction greater than grade 1
  • At least 4 weeks since prior immunotherapy
  • No prior carboxyamidotriazole
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Concurrent epoetin alfa allowed
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy
  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006486

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Walter Stadler Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006486     History of Changes
Other Study ID Numbers: NCI-2012-02364, CLB-69901, U10CA031946, CDR0000068317
Study First Received: November 6, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney 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 August 19, 2014