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Trial record 86 of 418 for:    mesothelioma

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant 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: NCT00295503
Recruitment Status : Completed
First Posted : February 23, 2006
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Collaborators:
University of Chicago
Columbia University
Duke University
Information provided by (Responsible Party):
Jonathan E. Dowell, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: bevacizumab
Drug: cisplatin
Drug: pemetrexed
Enrollment 53
Recruitment Details Patients recruited from investigators clinics
Pre-assignment Details  
Arm/Group Title Cisplatin, Pemetrexed and Bevacizumab
Hide Arm/Group Description cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
Period Title: Overall Study
Started 53
Completed 53
Not Completed 0
Arm/Group Title Cisplatin, Pemetrexed and Bevacizumab
Hide Arm/Group Description cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
one patient excluded due to ineligibility. That patient is included in the toxicity analysis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  46.2%
>=65 years
28
  53.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
66
(24 to 81)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
8
  15.4%
Male
44
  84.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants
52
1.Primary Outcome
Title Progression Free Survival Rate at 6 Months
Hide Description This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
Time Frame patients progression free at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin, Pemetrexed, Bevacizumab
Hide Arm/Group Description:
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
56
2.Secondary Outcome
Title Response Rate
Hide Description response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin, Pemetrexed, Bevacizumab
Hide Arm/Group Description:
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
40
3.Secondary Outcome
Title Overall Survival
Hide Description overall survival was measured from time of initiation of treatment to death from any cause
Time Frame from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin, Pemetrexed and Bevacizumab
Hide Arm/Group Description:
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: months
14.8
(10.0 to 17.0)
Time Frame 3 years 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Arm
Hide Arm/Group Description cisplatin, pemetrexed, and bevacizumab
All-Cause Mortality
Experimental Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Arm
Affected / at Risk (%) # Events
Total   16/53 (30.19%)    
Blood and lymphatic system disorders   
neutropenic fever *  1/53 (1.89%)  1
Gastrointestinal disorders   
small bowel obstruction *  1/53 (1.89%)  1
Constipation *  1/53 (1.89%)  1
General disorders   
Dehydration *  4/53 (7.55%)  4
Metabolism and nutrition disorders   
hypoglycemia *  1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders   
Pain *  1/53 (1.89%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
squamous cell carcinoma of the skin *  1/53 (1.89%)  1
Nervous system disorders   
RPLS *  1/53 (1.89%)  1
cerebrovascular accident *  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
pulmonary embolus *  5/53 (9.43%)  5
Vascular disorders   
deep venous thrombosis *  3/53 (5.66%)  3
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Experimental Arm
Affected / at Risk (%) # Events
Total   24/53 (45.28%)    
Blood and lymphatic system disorders   
Neutropenia * [1]  6/53 (11.32%)  6
Thrombocytopenia * [2]  2/53 (3.77%)  2
Anemia * [2]  1/53 (1.89%)  1
Gastrointestinal disorders   
Constipation * [2]  2/53 (3.77%)  2
Mucositis * [2]  1/53 (1.89%)  1
Vomiting * [2]  1/53 (1.89%)  1
General disorders   
Fatigue * [2]  4/53 (7.55%)  4
Dehydration * [2]  2/53 (3.77%)  2
Anorexia * [2]  1/53 (1.89%)  1
Immune system disorders   
Allergic reaction * [2]  1/53 (1.89%)  1
Nervous system disorders   
Neuropathy * [2]  2/53 (3.77%)  2
Renal and urinary disorders   
Creatinine * [2]  1/53 (1.89%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3/4 neutropenia only
[2]
Grade 3 and 4 only
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jonathan Dowell
Organization: UT Southwestern
Phone: 214-648-4180
Responsible Party: Jonathan E. Dowell, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00295503     History of Changes
Other Study ID Numbers: AVF3442S
First Submitted: February 22, 2006
First Posted: February 23, 2006
Results First Submitted: October 18, 2013
Results First Posted: January 5, 2017
Last Update Posted: January 5, 2017