University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial ctsu/E1505


A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (=/>4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC).

Type: Cancer Therapy
Phase: Phase III
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Anti-Angiogenesis, Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Barbara Gitlitz, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Gina Tse, R.N., Eduardo Mejia, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Must have undergone complete resection of their cancer - stage IB (>4 cm) - IIIA (T2-3 N0, T1-3 N1, T1-3 N2) NSCLC prior to enrollment. Accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling will be expected either at time of a pre-operative mediastinoscopy, or intra-operatively.
2Must 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.
3Age at least 18 years old.
4ECOG performance status 0 or 1.
5AGC = / >1.5; platelets = / >100,000.
6Total bilirubin < / = 1.5; SGOT & SGPT <5 x uln.
7Prothrombin time/INR < / = 1.5; PTT < / = inst uln.
8Creatinine < / = 1.5 x uln. Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio >0.5, 24-hour urine protein must be obtained and the level must be <1000 mg for patient enrollment.


You may not participate in this study if:
1Prior systemic chemotherapy at any time.
2Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy >5 years prior to enrollment that is now considered cured is acceptable.)
3Any history of cancer within 5 years from randomization, except in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
4History of MI 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.
5Any history of CVA or TIA.
6Pregnant or breastfeeding women. 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.
7Ongoing or active infection, symptomatic CHF, cardiac arrhythmia, psychiatric illness/social situations or any other medical condition that would limit compliance with study requirements.
8History of bleeding diathesis or coagulopathy.
9History of HTN - must be well controlled (<150/90) on a stable regimen of anti-hypertensive therapy.
10Patients receiving treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal). Patients receiving daily treatment with aspirin or NSAIDS are eligible.
11Serious non-healing wound, ulcer, bone fracture, or has 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.
12History of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to randomization.
13Any anticipated major surgical procedure(s) during the course of the study.
14Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
15Patients may be on a stable regimen of therapeutic anti-coagulation or may be receiving prophylactic anti-coagulation of venous access devices, provided that coagulation studies meet entry criteria 3.8. Caution must be exercised for patients requiring anti-coagulation, including treatment with low-dose heparin or low molecular weight heparin for DVT prophylaxis while on study due to an increased risk of bleeding with bevacizumab.
16Patients with ongoing post-op hemoptysis - defined as bright red blood of ½ teaspoon or more). Patients with pre-op hemoptysis that has resolved post-op are eligible.



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.