Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00003518|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : January 27, 2010
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 II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Testicular Germ Cell Tumor||Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 2|
OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the toxic effects of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Official Title:||Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||July 2002|
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): NCT00003518
|Study Chair:||Lawrence H. Einhorn, MD||Indiana University Melvin and Bren Simon Cancer Center|