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

United Kingdom Research and Innovation (UKRI)

Status and phase: Completed; Phase 2

Conditions: Testicular Germ Cell Tumor

Treatments: Drug: paclitaxel; Drug: cisplatin; Drug: ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00004077

MRC-TIP

EU-99012

CDR0000067286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Male

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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