Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003299|
Recruitment Status : Completed
First Posted : February 20, 2004
Last Update Posted : July 20, 2016
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 whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Drug: paclitaxel||Phase 3|
OBJECTIVES: I. Determine whether the addition of paclitaxel to standard chemotherapy treatment comprising etoposide and cisplatin improves the survival of patients with extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free survival of these patients treated with these regimens. III. Describe and compare the toxic effects associated with these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to performance status and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3. Arm II: Patients receive paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I. Patients then receive filgrastim (G-CSF) subcutaneously on days 4-18. Treatment repeats in both arms every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 2 months for 2 years, every 4 months for 1 year, and then at least every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 670 patients (335 per arm) will be accrued for this study within 16 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||587 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||January 2006|
|Active Comparator: Cisplatin + Etoposide||
|Experimental: Cisplatin + Etoposide + Paclitaxel||
- overall survival [ Time Frame: Up to 5 years ]
- response rate [ Time Frame: Up to 5 years ]
- failure-free survival [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003299
|Study Chair:||Harvey B. Niell, MD||Veterans Affairs Medical Center - Memphis|
|Study Chair:||Randolph S. Marks, MD||Mayo Clinic|
|Study Chair:||Alan B. Sandler, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||Karen Kelly, MD||University of Colorado, Denver|