This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
25 mg/day for 2 weeks, followed by 1 week of rest
On the first day of each cycle for 4 cycles
On the first day of each cycle for 4 cycles
Best Response
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Time frame: From randomization until disease progression/recurrence
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Incidence of Grade ≥ 3 Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
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