Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
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. It is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.
Drug: doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer|
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||October 1998|
- Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer.
- Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks.
- Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks.
Patients with stable or responding disease are treated for up to 5 courses.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003696
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|Study Chair:||Egbert F. Smit, MD||Free University Medical Center|