Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
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|ClinicalTrials.gov Identifier: NCT00393861|
Recruitment Status : Completed
First Posted : October 29, 2006
Results First Posted : January 29, 2015
Last Update Posted : March 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms, Germ Cell and Embryonal||Drug: Bevacizumab and Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||November 2014|
|Experimental: oxaliplatin & bevacizumab||
Drug: Bevacizumab and Oxaliplatin
Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
- Twelve Month Disease-free Survival Rate [ Time Frame: 12 month post completion of treatment ]The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.
- Objective Response Rate (Complete and Partial Response) [ Time Frame: completion of study, up to 5 years ]The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Remission (CR + PR) [ Time Frame: completion of study, up to 5 years ]Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
- Overall Survival [ Time Frame: completion of study, up to 5 years ]Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393861
|United States, Indiana|
|Indiana Univeristy Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|University of Pennsylvania:Abramson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Lawrence Einhorn, MD||Indiana Univeristy School of Medicine|