Clinical trial NCT00073112: A Study of ABT-751 in Patients With Renal Cell Cancer
Official title: A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility criteria: Inclusion Criteria

* Renal Cell Carcinoma.
* Recurrent tumor.
* At least 6 weeks post-nephrectomy.
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney, and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
* CNS metastasis.

Primary outcomes:
measure: Objective Response Rate in subjects with RCC
timeFrame: 1 year
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: 1 year
measure: Survival
timeFrame: 2 years
measure: Toxicities associated with treatment administration
timeFrame: 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Research Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Montebello
country: United States
facility: Clinical Trials + Research Associates
state: California
city: Denver
country: United States
facility: US Oncology Inc Rocky Mountain Cancer Centers
state: Colorado
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: New Port Richey
country: United States
facility: US Oncology Inc Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: US Oncology Inc Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: US Oncology Inc Cancer Centers of Florida, P.A.
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Cary
country: United States
facility: US Oncology Inc Raleigh Hematology Oncology Clinic
state: North Carolina
city: Kettering
country: United States
facility: US Oncology Inc Dayton Oncology & Hematology P.A.
state: Ohio
city: Oklahoma City
country: United States
facility: US Oncology Inc Cancer Care Accociates-Mercy Campus
state: Oklahoma
city: Greenville
country: United States
facility: US Oncology Inc Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: West Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Tyler
country: United States
facility: US Oncology Inc Tyler Cancer Center
state: Texas
city: Spokane
country: United States
facility: US Oncology Inc Cancer Care Northwest-North
state: Washington
city: Vancouver
country: United States
facility: US Oncology Inc Northwest Cancer Specialists
state: Washington
city: Vancouver
country: Canada
facility: B.C. Vancouver Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Science Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Abbott
name: Helen Eliopoulos, M.D.
role: STUDY_DIRECTOR
References: