Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295503
• Other study ID #: AVF3442S
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: August 2010

Study information

• Verified date: September 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Drug:
• bevacizumab
15 mg/kg IV every 3 weeks
• cisplatin
75 mg/m2 IV every 3 weeks
• pemetrexed
500 mg/m2 every 3 weeks

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Columbia University, Duke University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival Rate at 6 Months	This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.	patients progression free at 6 months
Secondary	Response Rate	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.	from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months
Secondary	Overall Survival	overall survival was measured from time of initiation of treatment to death from any cause	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 months