Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT00002559
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen
* Active disease meeting 1 of the following conditions:
* Measurable or evaluable disease
* Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin)
* Unresectable residual disease after postchemotherapy surgery
* Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following:
* No more than 1 prior regimen or 6 prior courses of cisplatin
* Testis or ovarian germ cell primary site
* Prior CR to cisplatin therapy
* Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin
PATIENT CHARACTERISTICS:
Age:
* 15 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8.0 g/dL
Hepatic:
* Not specified
Renal:
* Creatinine clearance greater than 50 mL/min
* Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator
Cardiovascular:
* If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry
Other:
* No active infection not well controlled on antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior paclitaxel or ifosfamide
* At least 3 weeks since prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
* Recovered from recent surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00002559
Study Brief:
Protocol Section:
NCT00002559