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Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
Columbia University
Duke University
Information provided by (Responsible Party):
Jonathan E. Dowell, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00295503
First received: February 22, 2006
Last updated: November 4, 2016
Last verified: November 2016

February 22, 2006
November 4, 2016
February 2006
June 2010   (Final data collection date for primary outcome measure)
Progression Free Survival Rate at 6 Months [ Time Frame: patients progression free at 6 months ]
This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
progression free survival
Complete list of historical versions of study NCT00295503 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months ]
    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.
  • Overall Survival [ 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. ]
    overall survival was measured from time of initiation of treatment to death from any cause
  • Response Rate
  • Overall Survival
Not Provided
Not Provided
 
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

Secondary endpoints will include:

objective response rate

overall survival

In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mesothelioma
  • Drug: bevacizumab
    15 mg/kg IV every 3 weeks
  • Drug: cisplatin
    75 mg/m2 IV every 3 weeks
  • Drug: pemetrexed
    500 mg/m2 every 3 weeks
Experimental: 1
cisplatin, pemetrexed, and bevacizumab
Interventions:
  • Drug: bevacizumab
  • Drug: cisplatin
  • Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
August 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion criteria

5.2.1 Patients must have histologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) not amenable to curative surgery or radiotherapy. Eligible sites of origin include the pleura, peritoneum, and tunica vaginalis.

5.2.2 Patient's disease must not be amenable to curative treatment with surgery. Evidence of gross unresectability will include but not be limited to direct extension into the chest wall, mediastinal or hilar lymphadenopathy, pulmonary or cardiac function that is inadequate to tolerate resection, and sarcomatoid or mixed histology.

5.2.3 Patients must be > 18 years old 5.2.4 Patients must have measurable disease.

Adequate organ function and functional status

Exclusion Criteria:

a. General Medical Concerns 5.3.1 Patients must not be pregnant or breast feeding. 5.3.2 No "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" second malignancy if they have completed therapy and have a less than 30% risk of relapse.

5.3.3 No uncontrolled intercurrent illness including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements.

5.3.4 No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications.

5.3.5 History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.

5.3.6 Inability to interrupt aspirin or other non-steroidal medication for a 5 day period.

c. Bevacizumab-Specific Concerns

Subjects meeting any of the following criteria are ineligible for study entry:

5.3.7 Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or CVA (stroke) within 6 months of study entry.

5.3.9 Evidence of bleeding diathesis or coagulopathy. Patients on therapeutic doses of coumadin are eligible as long as the INR is maintained in the range of 2-3 and there is no evidence of active bleeding.

5.3.10 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 5.3.11 Urine protein:creatinine ratio less than 1.0 at screening 5.3.12 Serious, non-healing wound, ulcer, or bone fracture

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00295503
AVF3442S
Yes
Not Provided
Not Provided
Not Provided
Jonathan E. Dowell, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
  • University of Chicago
  • Columbia University
  • Duke University
Principal Investigator: Jonathan E Dowell, MD University of Texas
University of Texas Southwestern Medical Center
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP