Brief Title
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Official Title
A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma
Brief Summary
To estimate the time to progression of cancer in patients with previously untreated
mesothelioma receiving cisplatin, pemetrexed and bevacizumab
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression Free Survival Rate at 6 Months
Secondary Outcome
Response Rate
Condition
Mesothelioma
Intervention
bevacizumab
Study Arms / Comparison Groups
1
Description: cisplatin, pemetrexed, and bevacizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
53
Start Date
February 2006
Completion Date
August 2010
Primary Completion Date
June 2010
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jonathan E Dowell, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00295503
Organization ID
AVF3442S
Responsible Party
Sponsor
Study Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Chicago
Study Sponsor
Jonathan E Dowell, MD, Principal Investigator, University of Texas
Verification Date
September 2020