Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00041015|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 9, 2014
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 more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Drug: topotecan hydrochloride||Phase 3|
- Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
- Compare the response rates, response duration, and time to progression in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the patient-perceived disease status and well being in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.
Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||November 2002|
Active Comparator: oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
|Drug: cisplatin Drug: topotecan hydrochloride|
Experimental: Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
|Drug: cisplatin Drug: etoposide|
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): NCT00041015
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Nathan Levitan, MD||Case Comprehensive Cancer Center|