- Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB
with malignant effusion (fluid cytology demonstrating malignant cells required),
Stage IV, or recurrent disease after definitive local therapy
- Candidate for primary treatment with cisplatin and gemcitabine
- Presence of measurable disease by RECIST
- Adequate organ function as defined by the following criteria: ECOG performance status
of 0 or 1
- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- One or more lung lesions with cavitation, or any lesion invading or abutting a major
blood vessel as assessed by CT or MRI.
- History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1
week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart.
- Untreated brain metastases.
- Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or
other medications known to inhibit platelet function.