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Phase III Randomized Study of Paclitaxel, Ifosfamide, and Cisplatin Versus Vinblastine, Ifosfamide, and Cisplatin as Second-Line Therapy in Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Alternate Title Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Special Category: CTSU trial Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patient Characteristics: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
[Note: *Unless hepatic metastases are present] Renal Other
Expected Enrollment A total of 470 patients (235 per treatment arm) will be accrued for this study within 5.5 years. Outline This is a randomized, multicenter study. Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months (yes vs no) and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. Trial Lead Organizations Cancer and Leukemia Group B
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. |
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