A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors
cisplatin
+ ifosfamide
+ paclitaxel
Urogenital Diseases+16
+ Genital Diseases
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: May 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the feasibility of combining paclitaxel, ifosfamide, and cisplatin induction in patients with metastatic nonseminomatous germ cell tumor of the testis in first relapse following first line treatment with bleomycin, etoposide, and cisplatin. Determine the response rates to this regimen in these patients OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours and ifosfamide IV and cisplatin IV daily for 5 days. Patients with stable or responding disease repeat treatment every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 16 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Metastatic nonseminomatous germ cell tumor of the testis In first relapse following first line treatment with bleomycin, etoposide, and cisplatin Biopsy proven germ cell tumor OR Rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin) No brain metastases PATIENT CHARACTERISTICS: Age: 16 to 64 Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Glomerular filtration rate greater than 50 mL/min Other: No other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior experimental drugs
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location