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Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

This study has been completed.
University of Chicago
Columbia University
Duke University
Information provided by (Responsible Party):
Jonathan E. Dowell, University of Texas Southwestern Medical Center Identifier:
First received: February 22, 2006
Last updated: November 4, 2016
Last verified: November 2016
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

Condition Intervention Phase
Mesothelioma Drug: bevacizumab Drug: cisplatin Drug: pemetrexed Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma

Resource links provided by NLM:

Further study details as provided by Jonathan E. Dowell, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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.

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 ]
    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

Enrollment: 53
Study Start Date: February 2006
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cisplatin, pemetrexed, and bevacizumab
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00295503

United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8852
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Chicago
Columbia University
Duke University
Principal Investigator: Jonathan E Dowell, MD University of Texas
  More Information

Responsible Party: Jonathan E. Dowell, Associate Professor, University of Texas Southwestern Medical Center Identifier: NCT00295503     History of Changes
Other Study ID Numbers: AVF3442S
Study First Received: February 22, 2006
Results First Received: October 18, 2013
Last Updated: November 4, 2016

Keywords provided by Jonathan E. Dowell, University of Texas Southwestern Medical Center:

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on September 19, 2017