Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors (NCT00070096) | Clinical Trial Compass
CompletedPhase 2
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
United States29 participantsStarted 2003-08
Plain-language summary
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.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
PATIENT CHARACTERISTICS:
Age
* 16 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No conc…