Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
NCT ID: NCT00003518
Last Updated: 2023-06-22
Study Results
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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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
1999-01-25
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.
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Detailed Description
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OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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gemcitabine hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since major surgery and recovered Other: At least 1 week since prior intravenous antibiotics No concurrent intravenous antibiotics
15 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Eastern Cooperative Oncology Group
Principal Investigators
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Lawrence H. Einhorn, MD
Role: STUDY_CHAIR
Indiana University Melvin and Bren Simon Cancer Center
Locations
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CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Kimball Medical Center
Lakewood, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
University of Rochester Cancer Center
Rochester, New York, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Pretoria Academic Hospital
Pretoria, , South Africa
Countries
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References
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Einhorn LH, Brames MJ, Juliar B, Williams SD. Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. J Clin Oncol. 2007 Feb 10;25(5):513-6. doi: 10.1200/JCO.2006.07.7271.
Hinton S, Catalano P, Einhorn LH, Loehrer PJ Sr, Kuzel T, Vaughn D, Wilding G. Phase II study of paclitaxel plus gemcitabine in refractory germ cell tumors (E9897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2002 Apr 1;20(7):1859-63. doi: 10.1200/JCO.2002.07.158.
Other Identifiers
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E9897
Identifier Type: -
Identifier Source: secondary_id
CDR0000066562
Identifier Type: -
Identifier Source: org_study_id
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