Lung Cancer Clinical Trial

A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer

Summary

The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P.

The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.

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Full Description

Lung cancer has become the leading cause of cancer death in both men and women in the US and Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment is available for advanced stages of the disease (stages III and IV), which comprise the majority of cases. Treatment with the combination of carboplatin and paclitaxel has been shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits vascular endothelial growth factor (VEGF), necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive tumor cell death as a consequence of oxygen and nutrient deprivation.

This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage IV disease
Measurable disease on CT scan (by the Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (which means able to independently care for self and to perform light work) .
Adequate blood counts
Adequate liver and kidney function
Subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.

Exclusion Criteria:

Predominant Squamous Cell NSCLC histology.
History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
Brain (CNS) metastasis by head CT scan or MRI
Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (PSA) of < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the Medical Monitor.
History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
Certain cardiac disorders such as recent myocardial infarction (MI), severe congestive heart failure, certain types of abnormal cardiac rhythm
Uncontrolled high blood pressure despite medications
Uncontrolled, clinically significant active infection.
Known HIV
Known hypersensitivity to any of the components of CA4P, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes.

Details of the above and additional inclusion and exclusion criteria can be discussed with an investigator.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00653939

Recruitment Status:

Completed

Sponsor:

Mateon Therapeutics

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There are 15 Locations for this study

See Locations Near You

Southbay Oncology Hematology
Campbell California, 95008, United States
Pacific Coast Hematology and Oncology Medical Group
Fountain Valley California, 92708, United States
UCLA Division of Hematology and Oncology
Los Angeles California, 90095, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill California, 94523, United States
Boca Raton Comprehensive Cancer Center
Boca Raton Florida, 21020, United States
Kentuckiana Cancer Institute
Louisville Kentucky, 40202, United States
Lahey Clinic Medical Center
Burlington Massachusetts, 01805, United States
The Center for Cancer and Hematologic Disease
Cherry Hill New Jersey, 08003, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
The Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Signal Point Clinical Research
Middletown Ohio, 45042, United States
Blueridge Cancer Care
Salem Virginia, 24153, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
Mary Babb Randolph Cancer Center-Clinical Trials Unit
Morgantown West Virginia, 26506, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00653939

Recruitment Status:

Completed

Sponsor:


Mateon Therapeutics

How clear is this clinincal trial information?

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