Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00070096|
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : June 24, 2013
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor||Drug: ixabepilone||Phase 2|
- Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
- Determine the safety of this drug in these patients.
OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL|
|Study Start Date :||August 2003|
|Actual Study Completion Date :||June 2007|
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): NCT00070096
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Gnanamba V. Kondagunta, MD||Memorial Sloan Kettering Cancer Center|