Topotecan and Vinorelbine in Treating Patients With Recurrent 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: NCT00287963|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : May 17, 2018
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: topotecan hydrochloride Drug: vinorelbine tartrate||Phase 1|
- Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.
- Assess the response and stable disease rates and the time to disease progression among treated patients.
OUTLINE: This is a dose-escalation study of topotecan.
Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|Experimental: Vinorelbine + topotecan||
Drug: topotecan hydrochloride
Drug: vinorelbine tartrate
- Maximum tolerated dose [ Time Frame: Cycle 1 (up to day 21) ]
- Response rate [ Time Frame: while on study, at the end of each 3 week cycle ]
- stable disease rate [ Time Frame: while on study, at the end of each 3 week cycle ]
- time to progression [ Time Frame: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months ]
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): NCT00287963
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Andrew S. Kraft, MD||Medical University of South Carolina|
|Study Chair:||Gustavo Leone||Medical University of South Carolina, Hollings Cancer Center|