Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
|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|
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|