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

Completed · Phase 2

Conditions studied: Tumors

In brief

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.

Key facts

Study ID

NCT00653939

Run by

Mateon Therapeutics

People needed

63

Starts

2008-03-01

Expected to finish

2011-10-01

Last updated by the study team

2015-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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