To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
|First Received Date||February 22, 2006|
|Last Changed Date||November 4, 2016|
|Start Date||February 2006|
|Actual Primary Completion Date||June 2010|
|Primary Outcome Measures||
Progression Free Survival Rate at 6 Months [Time Frame: patients progression free at 6 months]
|Secondary Outcome Measures||
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]
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.]
|Study Arms / Comparison Groups||1 / 0|
Secondary endpoints will include:
objective response rate
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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
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
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
|Responsible Party||Principal Investigator|
|Sponsor||University of Texas Southwestern Medical Center|
|Verification Date||November 2016|