NCT00003696

Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer

Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Commissie Voor Klinisch Toegepast Onderzoek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	etoposide
DRUG	paclitaxel

Timeline

• Start date: 1998-10-01
• First posted: 2003-01-27
• Last updated: 2013-09-17

Locations

1 site across 1 country: Netherlands