Clinical trial NCT00005045: Carboxyamidotriazole in Treating Patients With Advanced Kidney Cancer
Official title: Phase II Study of Carboxyamidotriazole (CAI, NSC #609974) in Patients With Advanced Renal Cell Carcinoma Refractory to Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have advanced kidney cancer that has not responded to biological therapy.

Detailed description: OBJECTIVES: I. Determine the disease free progression at 6 months in patients with locally recurrent or metastatic renal cell cancer (refractory to immunotherapy) treated with carboxyamidotriazole. II. Evaluate the progression free survival rate and response rate in these patients on this regimen. III. Evaluate the toxic effect of this regimen on these patients.

OUTLINE: Patients receive oral carboxyamidotriazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and every 12 months thereafter until death.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven advanced renal cell cancer Locally recurrent or metastatic lesions not amenable to current resection Progressive disease defined as 25% increase from last measurement or new lesions Bidimensionally measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and/or SGPT less than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious medical illness or active infection that would preclude chemotherapy compliance No other prior malignancy unless curatively treated and disease free for the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy At least 1 (but no more than 2) prior biologic regimen(s) (i.e., interleukin-2, interferon alfa, or combination) and recovered Regimen defined as at least 8 weeks of treatment Prior sargramostim allowed Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy (i.e., megestrol or tamoxifen) and recovered Radiotherapy: No prior radiotherapy to study lesions At least 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy Surgery: Prior nephrectomy allowed Recovered from any recent surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Los Angeles
country: United States
facility: Beckman Research Institute, City of Hope
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Medical Center - Palo Alto
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: CCOP - Colorado Cancer Research Program, Inc.
state: Colorado
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: Veterans Affairs Medical Center - Gainsville
state: Florida
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Tampa
country: United States
facility: Veterans Affairs Medical Center - Tampa (Haley)
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Veterans Affairs Medical Center - Indianapolis (Roudebush)
state: Indiana
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: MBCCOP - LSU Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Minneapolis
country: United States
facility: Veterans Affairs Medical Center - Minneapolis
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Hackensack
country: United States
facility: CCOP - Northern New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Veterans Affairs Medical Center - Albany
state: New York
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Brooklyn
country: United States
facility: Veterans Affairs Medical Center - Brooklyn
state: New York
city: New York
country: United States
facility: Veterans Affairs Medical Center - New York
state: New York
city: New York
country: United States
facility: Kaplan Cancer Center
state: New York
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Veterans Affairs Medical Center - Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Tulsa
country: United States
facility: CCOP - Sooner State
state: Oklahoma
city: Danville
country: United States
facility: CCOP - Geisinger Clinical and Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allegheny University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Affairs Medical Center - Pittsburgh
state: Pennsylvania
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: San Juan
country: Puerto Rico
facility: MBCCOP - San Juan
city: San Juan
country: Puerto Rico
facility: Veterans Affairs Medical Center - San Juan
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
Study officials:
affiliation: University of Pittsburgh
name: David Friedland, MD
role: STUDY_CHAIR
References:
citation: Dutcher JP, Leon L, Manola J, Friedland DM, Roth B, Wilding G; Eastern Cooperative Oncology Group. Phase II study of carboxyamidotriazole in patients with advanced renal cell carcinoma refractory to immunotherapy: E4896, an Eastern Cooperative Oncology Group Study. Cancer. 2005 Dec 1;104(11):2392-9. doi: 10.1002/cncr.21473.
citation: Friedland D, Leon L, Manola J, et al.: Carboxyamidotriazole (CAI) in patients with advanced renal cell cancer (RCC) refractory to immunotherapy: an ECOG phase II trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2424, 2002.