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A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients progressing on placebo to the proportion progressing on CAI

Outcome Time Frame:

Up to 16 weeks

Safety Issue:

No

Principal Investigator

Walter Stadler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02364

NCT ID:

NCT00006486

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606