Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
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ClinicalTrials.gov Identifier: NCT00004077 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Testicular Germ Cell Tumor | Drug: cisplatin Drug: ifosfamide Drug: paclitaxel | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Primary Purpose: | 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 |
Study Start Date : | May 1996 |
Actual Study Completion Date : | July 2005 |


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Ages Eligible for Study: | 16 Years to 64 Years (Child, Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004077
United Kingdom | |
Velindre Hospital | |
Cardiff, Wales, United Kingdom, CF14 2TL |
Study Chair: | Malcolm D. Mason, MD | Velindre NHS Trust |
ClinicalTrials.gov Identifier: | NCT00004077 |
Other Study ID Numbers: |
CDR0000067286 MRC-TIP EU-99012 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | December 19, 2013 |
Last Verified: | January 2001 |
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 |
Neoplasms, Germ Cell and Embryonal Testicular Neoplasms Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms Endocrine System Diseases Testicular Diseases Gonadal Disorders |
Paclitaxel Cisplatin Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |