Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
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|ClinicalTrials.gov Identifier: NCT00006043|
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : June 5, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic germ cell tumors that have not responded to cisplatin.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Testicular Germ Cell Tumor||Drug: temozolomide||Phase 2|
OBJECTIVES: I. Determine the efficacy of temozolomide in patients with cisplatin refractory metastatic germ cell tumors. II. Determine the safety of this treatment in these patients.
OUTLINE: Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study over 25 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||November 2001|
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): NCT00006043
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert J. Motzer, MD||Memorial Sloan Kettering Cancer Center|