Viewing Study NCT00004077



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Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00004077
Status: COMPLETED
Last Update Posted: 2013-12-19
First Post: 1999-12-10

Brief Title: Paclitaxel Ifosfamide and Cisplatin in Treating Patients With Metastatic Testicular Cancer
Sponsor: Medical Research Council
Organization: National Cancer Institute NCI

Study Overview

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
Status: COMPLETED
Status Verified Date: 2001-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
EU-99012 None None None
MRC-TIP None None None