Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Alliance for Clinical Trials in Oncology
- Study ID
- NCT00005972
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- gemcitabine hydrochloride — DRUG
- irinotecan hydrochloride — DRUG
Study Details
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.
Key Dates
- Start date
- May 31, 2000
- Status verified
- Jul 2016
- Primary completion
- Oct 31, 2006
- Completion
- Feb 29, 2008
Study Design
- Enrollment
- 73 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: gemcitabine + irinotecanPatients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.
Primary Outcome Measure
overall response rate [ Time Frame: Up to 18 weeks ]
Locations (50)
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Veterans Affairs Medical Center - Birmingham· Birmingham, ALUniversity of California San Diego Cancer Center· La Jolla, CAUCSF Cancer Center and Cancer Research Institute· San Francisco, CAVeterans Affairs Medical Center - San Francisco· San Francisco, CACCOP - Christiana Care Health Services· Wilmington, DELombardi Cancer Center· Washington D.C., DC
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