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A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma

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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

patients progression free at 6 months

Safety Issue:


Principal Investigator

Jonathan E Dowell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

August 2010

Related Keywords:

  • Mesothelioma
  • mesothelioma
  • bevacizumab
  • chemotherapy
  • Mesothelioma



University of Texas Southwestern Medical CenterDallas, Texas