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

November 6, 2000
January 15, 2013
October 2000
October 2005   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00006486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Drug: carboxyamidotriazole
    Given orally
    Other Names:
    • CAI
    • carboxyamido-triazole
    • carboxyaminoimidazole
  • Other: placebo
    Given orally
    Other Name: PLCB
  • 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.

    Intervention: Drug: carboxyamidotriazole
  • 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.

    Interventions:
    • Drug: carboxyamidotriazole
    • Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
335
Not Provided
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006486
NCI-2012-02364, CLB-69901, U10CA031946, CDR0000068317
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Walter Stadler Cancer and Leukemia Group B
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP