Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
- Registration Number
- NCT00010218
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
- Detailed Description
OBJECTIVES:
* Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy.
* Determine the effect of prior response to chemotherapy on response to this drug in these patients.
* Determine survival and failure-free survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these patients.
OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description karenitecin karenitecin Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States