Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

NCT00295503 | Completed Phase 2 Results DMC

• 1 other identifier: AVF3442S
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mesothelioma

Keywords

mesothelioma; bevacizumab; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Response Rate

  from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months

• Overall Survival

  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

Study Arms (1)

1

EXPERIMENTAL

cisplatin, pemetrexed, and bevacizumab

Drug: bevacizumab; Drug: cisplatin; Drug: pemetrexed

Interventions

bevacizumab DRUG

15 mg/kg IV every 3 weeks

1

cisplatin DRUG

75 mg/m2 IV every 3 weeks

1

pemetrexed DRUG

500 mg/m2 every 3 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients must be \> 18 years old 5.2.4 Patients must have measurable disease.
• Adequate organ function and functional status

You may not qualify if:

• 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.
• 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.
• No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.
• 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:
• Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or CVA (stroke) within 6 months of study entry.
• 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.
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of Chicago: collaborator
• Columbia University: collaborator
• Duke University: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8852, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Bevacizumab; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Jonathan Dowell
• Organization: UT Southwestern

jonathan.dowell@utsouthwestern.edu

214-648-4180

Study Officials

• Jonathan E Dowell, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2006
• First Posted: February 23, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 20, 2020
• Results First Posted: January 5, 2017

Record last verified: 2020-09

Locations

US (1)