Official Title: “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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Primary:

• progression free survival patients progression free at 6 months No

Secondary:

• response rate at time of best response No
• overall survival estimated at study completion No

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

Lead Sponsor: University of Texas Southwestern Medical Center

University of Texas Southwestern Medical Center

Dallas Texas 75390-8852 United States

Overall Clinical Trial Officials and Contacts

Jonathan E Dowell, MD Principal Investigator University of Texas Southwestern  

Overall Contact: Jonathan E Dowell, MD 214-648-4180 jonathan.dowell@utsouthwestern.edu

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295503

Study ID Number: AVF3442S

ClinicalTrials.gov Identifier: NCT00295503

Health Authority: United States: Food and Drug Administration