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Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

Primary Purpose

Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
cisplatin
pemetrexed
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring mesothelioma, bevacizumab, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

cisplatin, pemetrexed, and bevacizumab

Outcomes

Primary Outcome Measures

Progression Free Survival Rate 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
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
overall survival was measured from time of initiation of treatment to death from any cause

Full Information

First Posted
February 22, 2006
Last Updated
September 30, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Chicago, Columbia University, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00295503
Brief Title
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Official Title
A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Chicago, Columbia University, Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
mesothelioma, bevacizumab, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
cisplatin, pemetrexed, and bevacizumab
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
15 mg/kg IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m2 IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
500 mg/m2 every 3 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival Rate at 6 Months
Description
This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
Time Frame
patients progression free at 6 months
Secondary Outcome Measure Information:
Title
Response Rate
Description
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.
Time Frame
from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months
Title
Overall Survival
Description
overall survival was measured from time of initiation of treatment to death from any cause
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan E Dowell, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8852
Country
United States

12. IPD Sharing Statement

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Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

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