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| Sponsored by: |
Medical Research Council |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004077 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Testicular Germ Cell Tumor |
Drug: cisplatin Drug: ifosfamide Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | May 1996 |
OBJECTIVES:
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| Ages Eligible for Study: | 16 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic nonseminomatous germ cell tumor of the testis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations More Information
| Study ID Numbers: | CDR0000067286, MRC-TIP, EU-99012 |
| Study First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004077 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 Cancer Choriocarcinoma Antimitotic Agents Testicular Neoplasms Recurrence Carcinoma Ifosfamide Cisplatin Radiation-Sensitizing Agents |
Paclitaxel Neoplasms, Germ Cell and Embryonal Mechlorethamine Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Teratoma Isophosphamide mustard |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Pharmacologic Actions Neoplasms Ifosfamide Cisplatin |
Radiation-Sensitizing Agents Paclitaxel Neoplasms, Germ Cell and Embryonal Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Isophosphamide mustard |
