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Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer



Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

For Condition: Reproductive Cancer,Testicular Cancer
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/64 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MalcolmMason,  Study Chair,  Velindre Hospital

Velindre Hospital
Cardiff,  Wales,  CF14 2TL
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000067286;  MRC-TIP,EU-99012
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004077

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4. Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

5. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

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