Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Prog… (NCT00072215) | Clinical Trial Compass
TerminatedPhase 3
Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Stopped: poor accrual
United States1 participantsStarted 2004-04
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors.
PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.
Who can participate
Age range18 Years – 120 Years
SexMALE
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DISEASE CHARACTERISTICS:
* Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites:
* Seminoma
* Testis
* Retroperitoneum
* Mediastinum
* Other extragonadal site
* Nonseminoma
* Testis
* Retroperitoneum
* Other extragonadal site
* No tumor of the mediastinum
* Must have evidence of metastatic disease, including either of the following:
* Unidimensionally measurable lesions
* At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI
* Nonmeasurable lesions, including the following:
* Small lesions
* Bone lesions
* Pleural or pericardial effusions
* Ascites
* Irradiated lesions, unless progression is documented after radiotherapy
* Progressive or recurrent disease meeting at least 1 of the following criteria:
* Measurable progressive disease
* Biopsy-proven residual disease
* Persistently elevated or rising Ăź-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation
* Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*:
* Progressive GCT after a partial response to first-line t…