A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00674206|
Recruitment Status : Terminated (Sponsor funding stopped)
First Posted : May 7, 2008
Results First Posted : July 26, 2012
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Gemcitabine Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||October 2009|
Experimental: Gemcitabine and Oxaliplatin
All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
Gemcitabine 1000mg/m^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
Other Name: Gemcitabine, OxaliplatinDrug: Oxaliplatin
Oxaliplatin 100mg/m^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
- Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease. [ Time Frame: 8 weeks ]
A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.
Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Overall Survival From Time of Study Entry [ Time Frame: 132 weeks ]
The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.
Note: Not all patients started the study at the same time so the time frame is different from the full range.
The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived.
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): NCT00674206
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Amelia Zelnak, MD||Emory University Winship Cancer Institute|