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

NCT ID: NCT00004077

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Testicular Germ Cell Tumor

Keywords

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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 Design

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Primary Study Purpose

TREATMENT

Interventions

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cisplatin

Intervention Type DRUG

ifosfamide

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Malcolm D. Mason, MD

Role: STUDY_CHAIR

Velindre NHS Trust

Locations

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Velindre Hospital

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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Mead GM, Cullen MH, Huddart R, Harper P, Rustin GJ, Cook PA, Stenning SP, Mason M; MRC Testicular Tumour Working Party. A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial. Br J Cancer. 2005 Jul 25;93(2):178-84. doi: 10.1038/sj.bjc.6602682.

Reference Type RESULT
PMID: 15999102 (View on PubMed)

Other Identifiers

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MRC-TIP

Identifier Type: -

Identifier Source: secondary_id

EU-99012

Identifier Type: -

Identifier Source: secondary_id

CDR0000067286

Identifier Type: -

Identifier Source: org_study_id