Clinical trial NCT00073151: A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
Official title: A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 30
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 non-small cell lung 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

* Stage IIIB or IV non-small cell lung cancer.
* Recurrent tumor following treatment with paclitaxel or docetaxel.
* 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 NSCLC
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: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Greenbaum Cancer Center
state: Maryland
city: Kansas City
country: United States
facility: Oncology & Hematology Associates of Kansas City, PA
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology
state: North Carolina
city: Kettering
country: United States
facility: Dayton Oncology and Hematology
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: West Cancer Clinic
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Ft. Worth
country: United States
facility: Texas Oncology
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: Abbott
name: Helen Eliopoulos, MD
role: STUDY_DIRECTOR
References: