A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors
16 Years
64 Years
Male
Testicular Germ Cell Tumor
Trial Information
A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Malcolm D. Mason, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Velindre NHS Trust
Authority:
United States: Federal Government
Study ID:
CDR0000067286
NCT ID:
NCT00004077
Start Date:
May 1996
Completion Date:
Related Keywords:
- Testicular Germ Cell Tumor
- stage III malignant testicular germ cell tumor
- recurrent malignant testicular germ cell tumor
- testicular embryonal carcinoma
- testicular choriocarcinoma
- testicular teratoma
- testicular yolk sac tumor
- testicular embryonal carcinoma and teratoma
- testicular embryonal carcinoma and yolk sac tumor
- testicular yolk sac tumor and teratoma
- testicular choriocarcinoma and yolk sac tumor
- testicular choriocarcinoma and embryonal carcinoma
- testicular choriocarcinoma and teratoma
- Testicular Neoplasms
- Neoplasms, Germ Cell and Embryonal
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