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OpenTrials
Completed

NCT Number: NCT00004077

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

ifosfamide

Drug

paclitaxel

Drug

Sponsors and collaborators

Lead sponsor

Medical Research Council

Other Gov

Registry information

Official study 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

Important dates

Study start
1996
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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