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A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Gemcitabine
Drug: Oxaliplatin
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm Study
Hide Arm/Group Description All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Single Arm Study
Hide Arm/Group Description All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Participants
Number Analyzed 6 participants
55
(32 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Oxaliplatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Stable Disease 4
Partial Response 2
2.Secondary Outcome
Title Overall Survival From Time of Study Entry
Hide Description

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.

Time Frame 132 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Oxaliplatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Weeks
62
(13 to 86)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Study
Hide Arm/Group Description All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
All-Cause Mortality
Single Arm Study
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Single Arm Study
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Blood and lymphatic system disorders   
Neutropenia  1/6 (16.67%)  6
Infections and infestations   
Infection  1/6 (16.67%)  6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Study
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Platelets  2/6 (33.33%) 
Hemoglobin  1/6 (16.67%) 
General disorders   
Fatigue  1/6 (16.67%) 
Nausea  2/6 (33.33%) 
Nervous system disorders   
Neuropathy  1/6 (16.67%) 
Early termination of the study due to slow accrual
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amelia Zelnak
Organization: Emory University
Phone: 404-778-1900
EMail: amelia.zelnak@emoryhealthcare.org
Layout table for additonal information
Responsible Party: Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier: NCT00674206    
Other Study ID Numbers: IRB00007792
7792 ( Other Identifier: Other )
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: March 30, 2012
Results First Posted: July 26, 2012
Last Update Posted: December 12, 2013