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: Open to Accrual
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
1	Must 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.
2	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.
3	Age at least 18 years old.
4	ECOG performance status 0 or 1.
5	AGC = / >1.5; platelets = / >100,000.
6	Total bilirubin < / = 1.5; SGOT & SGPT <5 x uln.
7	Prothrombin time/INR < / = 1.5; PTT < / = inst uln.
8	Creatinine < / = 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:

1	Prior systemic chemotherapy at any time.
2	Hormonal 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.)
3	Any history of cancer within 5 years from randomization, except in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
4	History 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.
5	Any history of CVA or TIA.
6	Pregnant 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.
7	Ongoing or active infection, symptomatic CHF, cardiac arrhythmia, psychiatric illness/social situations or any other medical condition that would limit compliance with study requirements.
8	History of bleeding diathesis or coagulopathy.
9	History of HTN - must be well controlled (<150/90) on a stable regimen of anti-hypertensive therapy.
10	Patients receiving treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal). Patients receiving daily treatment with aspirin or NSAIDS are eligible.
11	Serious 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.
12	History of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to randomization.
13	Any anticipated major surgical procedure(s) during the course of the study.
14	Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
15	Patients 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.
16	Patients 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.