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
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | December 10, 1999 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | December 19, 2013 | |||
Study Start Date ICMJE | May 1996 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer | |||
Official Title ICMJE | A Study of Paclitaxel, Cisplatin and Ifosfamide as Induction Therapy in the Treatment of Patients Relapsing After BEP Chemotherapy for Metastatic Germ Cell Tumors | |||
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. |
|||
Detailed Description | OBJECTIVES:
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Testicular Germ Cell Tumor | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Not Provided | |||
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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
25 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | July 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 16 Years to 64 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00004077 | |||
Other Study ID Numbers ICMJE | CDR0000067286 MRC-TIP EU-99012 |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Medical Research Council | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | National Cancer Institute (NCI) | |||
Verification Date | January 2001 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |