Gemcitabine Plus Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Solid Tumor
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|ClinicalTrials.gov Identifier: NCT00004159|
Recruitment Status : Terminated
First Posted : July 26, 2004
Last Update Posted : November 20, 2013
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.
PURPOSE: Phase I/II trial to study the effectiveness of gemcitabine plus paclitaxel in treating patients who have advanced non-small cell lung cancer or other solid tumor.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 1 Phase 2|
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of biweekly administration of gemcitabine and paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumor. II. Determine the response rate, duration of response, and disease free interval for this patient population after this therapy.
OUTLINE: This is a dose escalation study. Patients receive paclitaxel IV over 1 hour followed 2 hours later by gemcitabine IV over 30 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for a maximum of 8 courses. Cohorts of 3-5 patients receive escalating doses of paclitaxel and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicity. Once the MTD is reached, an additional 14 patients (chemotherapy naive) with advanced NSCLC are treated at the recommended phase II dose. Patients are followed every 8 weeks for 6 months.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion and a total of 14 patients will be accrued for the phase II portion of this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Official Title:||Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||February 2000|
|Actual Study Completion Date :||February 2000|
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): NCT00004159
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|Study Chair:||Francisco Robert, MD, FACP||University of Alabama at Birmingham|