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Sponsors and Collaborators: |
Indiana University School of Medicine Genentech |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00393861 |
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
Condition | Intervention | Phase |
---|---|---|
Neoplasms, Germ Cell and Embryonal |
Drug: Bevacizumab and Oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors |
Estimated Enrollment: | 18 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
NOTE THE FOLLOWING GUIDELINES FOR USE IN THIS PROTOCOL:
Contact: Jackie Brames, RN | 317-274-7929 | mjbrames@iupui.edu |
Contact: Erin Pennington | 317-278-4271 | erpennin@iupui.edu |
United States, Indiana | |
Indiana Univeristy Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Jackie Brames, RN 317-274-7929 mjbrames@iupui.edu | |
Principal Investigator: Lawrence Einhorn, MD | |
United States, Pennsylvania | |
University of Pennsylvania:Abramson Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Janelle Robinson 215-662-7398 Janelle.Robinson@uphs.upenn.edu | |
Principal Investigator: David Vaughn, MD |
Principal Investigator: | Lawrence Einhorn, MD | Indiana Univeristy School of Medicine |
Responsible Party: | Indiana University Cancer Center ( Lawrence Einhorn, MD/ Principal Investigator ) |
Study ID Numbers: | 0609-11, IUCRO-0166, AVF4003s |
Study First Received: | October 26, 2006 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00393861 |
Health Authority: | United States: Institutional Review Board |
Germ Cell Tumor Germ Cell Cancer |
Oxaliplatin Neoplasms, Germ Cell and Embryonal Bevacizumab Malignant germ cell tumor |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |