Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
- Registration Number
- NCT00003666
- 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 irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HMAF 6-hydroxymethylacylfulvene treatment of refractory or relapsed NSCLC with HMAF
- Primary Outcome Measures
Name Time Method Response ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression
- Secondary Outcome Measures
Name Time Method Toxicity Each tx cycle
Trial Locations
- Locations (48)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸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
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Scroll for more (38 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States