E1505 - A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB (Y4cm)-IIIA Non-Small Cell Lung Cancer (NSCLC)
The objective of this study is to evaluate overall survival with chemotherapy with or without Bevacizumab used in the adjuvant setting in patients with resected stage IB (>4cm) - IIIA NSCLC.
In order to be eligible for this trial, patients must have undergone complete resection of their cancer [stage IB (greater than 4 cm) - IIIA (T2-3N0, T1-3N1, T1-3N2) non-small cell lung cancer (NSCLC)] prior to enrollment.
If patient’s tumor is stage IB, it must be greater than 4 cm in size.
Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
Age greater than 18 years.
ECOG performance status 0 or 1.
No prior systemic chemotherapy at any time.
No hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization.
Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
Required laboratory values obtained within two weeks of randomization per protocol.
Patients must have adequate renal function as determined by required blood work 2 weeks prior to randomization.
Patients with a history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization.
Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial.
Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk from bevacizumab. It is also unknown if these agents are excreted into breast milk.
All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy.
Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab.
Patients must not have ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness/social situations or any other medical condition that would limit compliance with study requirements.
Patients must have no history of bleeding diathesis or coagulopathy.
Patients with a history of hypertension must be well controlled (less than 150/90) on a stable regimen of anti-hypertensive therapy.
Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible.
Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or core biopsy within 7 days prior to randomization.
Patients must not have a history of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to randomization.
Patients must not have any anticipated major surgical procedure(s) during the course of the study.
Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet study criteria.
Patients with ongoing post-operative hemoptysis (defined as bright red blood of ½ teaspoon or more) are not eligible. Patients with pre-operative hemoptysis that has resolved postoperatively are eligible.
Nancy N. and J.C. Lewis Cancer & Research Pavilion
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405