AboutMesothelioma.Net

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

Saturday, March 1, 2008

Date First Received: February 22, 2006
Last Updated: September 15, 2006
Verified by: University of Texas Southwestern Medical Center
Clinical Trial Phase: Phase 2 Start Date: February 2006
Overall Status: Recruiting
Estimated Enrollment: 65

Brief Summary

Condition Keyword(s): Mesothelioma

Intervention(s):
Drug: bevacizumab
Drug: cisplatin
Drug: pemetrexed

Rationale

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.

Outcome Measures for this Clinical Trial

Primary: progression free survival

Secondary: response rate; overall survival

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

• 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.
• 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 1.0 at screening (see appendix F for³Urine protein:creatinine ratio instructions on calculating the ratio) 5.3.12 Serious, non-healing wound, ulcer, or bone fracture

Clinical Trials Locations, Contact Details, and Sponsors

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

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

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

Study ID Number: AVF3442S

ClinicalTrials.gov Identifier: NCT00295503

Labels: ClinicalTrial

posted by Your Attorney at 1:48 PM
Link to this article