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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center University of Chicago Columbia University |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00295503 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma |
Estimated Enrollment: | 65 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
cisplatin, pemetrexed, and bevacizumab
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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
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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 |
Genders Eligible for Study: | Both |
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
Contact: Jonathan E Dowell, MD | 214-648-4180 | jonathan.dowell@utsouthwestern.edu |
Contact: Erin Fenske | 214-648-7097 | erin.fenske@utsouthwestern.edu |
United States, Texas | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390-8852 | |
Contact: Jonathan E Dowell, MD 214-648-7070 jonathan.dowell@utsouthwestern.edu | |
Contact: Laura Crittenden 214-857-0208 | |
Principal Investigator: Jonathan E Dowell, MD |
Principal Investigator: | Jonathan E Dowell, MD | University of Texas Southwestern |
Responsible Party: | UT Southwestern ( Jonathan E. Dowell ) |
Study ID Numbers: | AVF3442S |
Study First Received: | February 22, 2006 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00295503 |
Health Authority: | United States: Food and Drug Administration |
mesothelioma bevacizumab chemotherapy |
Folic Acid Pemetrexed Cisplatin Mesothelioma |
Bevacizumab Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |