Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma

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: NCT00859469
Recruitment Status : Unknown
Verified January 2012 by Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2009
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Intervention Drug: Oxaliplatin/Gemcitabine
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 29
6 Cycles 16
Completed 1
Not Completed 28
Reason Not Completed
Adverse Event             2
Lack of Efficacy             9
Withdrawal by Subject             1
Death             16
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  55.2%
>=65 years
13
  44.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
63.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
9
  31.0%
Male
20
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
Primary Site   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants
Pleural 16
Peritoneal 13
[1]
Measure Description: Pleural vs. Peritoneal
Pathologic Subtype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants
Epithelioid 19
Sarcomatoid 3
Biphasic 7
[1]
Measure Description: Epithelioid vs. Sarcomatoid vs. Biphasic
Prior chemotherapy regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants
0 11
1 or more 18
1.Primary Outcome
Title Best Response
Hide Description Radiologic response by RECIST criteria
Time Frame Two months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat principle
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 7
Stable Disease 11
Progressive Disease 11
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
8
(4 to 14)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Time to radiologic disease progression or death
Time Frame 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
5
(2 to 7)
Time Frame 50 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxaliplatin and Gemcitabine
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Oxaliplatin and Gemcitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin and Gemcitabine
Affected / at Risk (%)
Total   11/28 (39.29%) 
Blood and lymphatic system disorders   
Anemia * 1  3/28 (10.71%) 
Thrombocytopenia * 1  1/28 (3.57%) 
Leukopenia * 1  3/28 (10.71%) 
Hepatobiliary disorders   
Elevated alkaline phosphatase * 1  3/28 (10.71%) 
Elevated AST * 1  3/28 (10.71%) 
Elevated ALT * 1  3/28 (10.71%) 
Elevated Bilirubin * 1  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/28 (3.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxaliplatin and Gemcitabine
Affected / at Risk (%)
Total   27 
Blood and lymphatic system disorders   
Leukopenia * 1  5/26 (19.23%) 
Thrombocytopenia * 1  16/28 (57.14%) 
Anemia * 1  23/26 (88.46%) 
Gastrointestinal disorders   
Nausea/Vomiting * 1  9/29 (31.03%) 
Diarrhea * 1  2/29 (6.90%) 
General disorders   
Fever * 1  2/29 (6.90%) 
Hepatobiliary disorders   
Elevated alkaline phosphatase * 1  15/26 (57.69%) 
Elevated AST * 1  13/26 (50.00%) 
Elevated ALT * 1  14/26 (53.85%) 
Nervous system disorders   
Peripheral neuropathy * 1  11/29 (37.93%) 
Vertigo * 1  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  4/28 (14.29%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  2/29 (6.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joshua Leinwand
Organization: Columbia University
Phone: 212-305-4076
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00859469     History of Changes
Other Study ID Numbers: AAAA2861 (Final)
First Submitted: March 9, 2009
First Posted: March 11, 2009
Results First Submitted: January 20, 2012
Results First Posted: February 24, 2012
Last Update Posted: February 24, 2012