A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent
- Histologically or cytologically confirmed NSCLC
- Advanced NSCLC
- Measurable disease
- ECOG performance status of 0 or 1
- Age ≥ 18 years
- Use of accepted and effective method of contraception, i.e., double barrier
contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course
of the study and for 6 months after the last study treatment administration for
women, and 1 month for men
Exclusion Criteria:
- Squamous cell histology
- Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ
cervical cancer), unless it has been treated with curative intent and there is no
evidence of disease for ≥ 3 years prior to randomization
- Untreated or unstable CNS metastases
- Myocardial infarction or an unstable or uncontrolled disease or condition related to
or impacting cardiac function within 1 year prior to randomization
- Uncontrolled hypertension
- History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year
prior to randomization
- Major surgical procedure within 28 days prior to randomization
- Serious non-healing wound ulcer, or bone fracture within 21 days prior to
randomization
- Persistent history of gross hemoptysis relating to the patient's NSCLC
- Known HIV infection
- Known to be positive for hepatitis C or hepatitis B surface antigen
- Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known
to inhibit platelet function
- Use of anticoagulation therapy
- Participation in clinical trials or undergoing other investigational procedures
within 30 days prior to randomization
- Pregnancy (e.g., positive HCG test) or breast feeding
- Known sensitivity to any of the products to be administered during the study
- Any disorder that compromises the ability of the patient to provide written informed
consent and/or to comply with study procedures