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Phase II Study of Ixabepilone in Patients With Metastatic Cisplatin-Refractory Germ Cell Tumors
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Completed
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16 and over
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NCI
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MSKCC-03041
NCI-6022, 6022, NCT00070096
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Objectives - Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
- Determine the safety of this drug in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
- Measurable metastatic disease by one of the following methods:
- Radiography
- If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
- Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
- Previously treated progressive disease meeting 1 of the following criteria:
- Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
- Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
- Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)
Prior/Concurrent Therapy:
Biologic therapy - No concurrent immunotherapy
Chemotherapy - See Disease Characteristics
- No other concurrent cytotoxic chemotherapy
Endocrine therapy Radiotherapy - See Disease Characteristics
- No concurrent radiotherapy
Surgery Other - No other concurrent experimental or commercial anticancer medications or therapies
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic - Bilirubin no greater than 1.5 times normal
- SGOT no greater than 2 times upper limit of normal
Renal - Creatinine no greater than 2.2 mg/dL
Other - Not pregnant or nursing
- Negative pregnancy test
- No active infection
Expected Enrollment 29A total of 10-29 patients will be accrued for this study within 1.3-4 years. Outcomes Primary Outcome(s)Efficacy
Safety
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.
Trial Contact Information
Trial Lead Organizations Memorial Sloan-Kettering Cancer Center | | | | Gnanamba Kondagunta, MD, Principal investigator | | | Ph: 646-422-4306; 800-525-2225 |
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| Registry Information | | | Official Title | | A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL | | | Trial Start Date | | 2003-08-14 | | | Registered in ClinicalTrials.gov | | NCT00070096 | | | Date Submitted to PDQ | | 2003-08-14 | | | Information Last Verified | | 2006-04-01 | | | NCI Grant/Contract Number | | CA08748, CM17105 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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