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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004077
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Testicular Germ Cell Tumor Drug: cisplatin Drug: ifosfamide Drug: paclitaxel Phase 2

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.


Study Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes 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
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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


Locations
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United Kingdom
Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Sponsors and Collaborators
Medical Research Council
Investigators
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Study Chair: Malcolm D. Mason, MD Velindre NHS Trust
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00004077     History of Changes
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
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
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Paclitaxel
 Albumin-Bound Paclitaxel
Cisplatin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents