Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Testicular Germ Cell Tumor
Intervention: cisplatin (Drug); ifosfamide (Drug); paclitaxel (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Medical Research Council Official(s) and/or principal investigator(s):
Malcolm D. Mason, MD, Study Chair, Affiliation: Velindre NHS Trust
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, ifosfamide, and
cisplatin in treating patients who have metastatic testicular cancer that has recurred
following treatment.
Clinical Details
Official title: A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 64 Years.
Gender(s): Male.
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
Locations and Contacts
Velindre Hospital, Cardiff, Wales CF14 2TL, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1996
Last updated: May 23, 2008
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