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

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics:   Cancer    Testicular Cancer   

Drug Information available for:   Ifosfamide    Cisplatin    Paclitaxel   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   25
Study Start Date:   May 1996

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.

  Eligibility
Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004077

Locations
United Kingdom, Wales
Velindre Hospital    
      Cardiff, Wales, United Kingdom, CF14 2TL

Sponsors and Collaborators
Medical Research Council

Investigators
Study Chair:     Malcolm D. Mason, MD     Velindre NHS Trust    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067286, MRC-TIP, EU-99012
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004077
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Ifosfamide
Cisplatin
Paclitaxel
Mechlorethamine
Neoplasms, Germ Cell and Embryonal
Choriocarcinoma
Testicular cancer
Testicular Neoplasms
Teratoma
Recurrence
Isophosphamide mustard
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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