Status:
COMPLETED
A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer
Lead Sponsor:
Mateon Therapeutics
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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), carboplat...
Detailed 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 approximat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00653939
Start Date
March 1 2008
End Date
October 1 2011
Last Update
February 9 2015
Active Locations (15)
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1
Southbay Oncology Hematology
Campbell, California, United States, 95008
2
Pacific Coast Hematology and Oncology Medical Group
Fountain Valley, California, United States, 92708
3
UCLA Division of Hematology and Oncology
Los Angeles, California, United States, 90095
4
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States, 94523