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

A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004077

Enrollment

Registered

2003-01-27

Start date

1996-05-31

Completion date

2005-07-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Germ Cell Tumor

Keywords

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

Brief 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.

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.

Interventions

DRUGcisplatin

DRUGifosfamide

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

16 Years to 64 Years

Healthy volunteers

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026