Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer - Full Text View

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 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Testicular Cancer

Drug Information available for: Ifosfamide Cisplatin Paclitaxel

Genetic and Rare Diseases Information Center resources: Testicular Cancer Choriocarcinoma Embryonal Carcinoma Testicular Yolk Sac Tumor

U.S. FDA Resources

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


Estimated Enrollment:	25
Study Start Date:	May 1996
Study Completion Date:	July 2005

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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United Kingdom
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

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00004077 History of Changes
Other Study ID Numbers:	CDR0000067286 MRC-TIP EU-99012
Study First Received:	December 10, 1999
Last Updated:	December 18, 2013
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

Additional relevant MeSH terms:


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	Isophosphamide mustard Albumin-Bound Paclitaxel Cisplatin Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents

ClinicalTrials.gov processed this record on September 27, 2016