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Therapeutic Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Lung Cancer
Location: United States, FL
Clinical Trial Details
Research Study Summary
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)
In order to be eligible for this trial, patients must have undergone complete resection of their
non-small cell lung cancer (NSCLC) [stage IB (> 4 cm)] – [IIIA (T2-3N0, T1-3N1, T1-3N2]
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 at specified levels is required pre-operatively
(mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5
and/or 6 for left sided tumors). Please refer to Section 5 for specific details on lymph node
level sampling requirements and resection criteria.
- If patient’s tumor is stage IB, it must be > 4 cm in size.
Required laboratory values obtained within two weeks of randomization:
- Patients must be no less than 6 weeks (42 days) and no more than 12 weeks (84 days)
post-thoracotomy at the time of randomization and must be adequately recovered from
- Age > 18 years.
- ECOG performance status 0 or 1.
- Patients must not have received the following:
- Prior systemic chemotherapy at any time. Methotrexate (MTX) given in low doses for
non-malignant conditions with last dose at least 2 weeks prior to date of registration
will be allowed. Other low dose chemotherapeutics for non-malignant conditions will
be considered, but review by the study chair is required.
- 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 over 5 years prior to enrollment that is now
considered cured is acceptable.)
- 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
Patients must have adequate renal function as determined by the following tests within
2 weeks prior to randomization:
- ANC = 1500 mm3
- Platelets = 100,000/mm3
- Prothrombin time/INR = 1.5
- Or, if patient is on therapeutic anticoagulation, prothrombin time/INR < 3.0
- Is patient on therapeutic anticoagulation?
- PTT = institutional upper limit of normal (ULN) OR, if patient is on therapeutic
anticoagulation, PTT must be < 1.5 x ULN.
- Is patient on therapeutic anticoagulation? _______ (Yes or No)
- Total Bilirubin = 1.5 mg/dL
- SGOT (AST) < 5 x upper limit of normal (ULN):
- Institutional Upper Limit of Normal: ___________________________
- SGPT (ALT) < 5 x upper limit of normal (ULN):
- Serum Creatinine = 1.5 x institutional upper limit of normal (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.
- Patients with a known 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 any clinically significant ongoing, active or serious infection,
symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac
arrhythmia or any other medical condition or psychiatric illness/social situations that would
limit compliance with study requirements.
- Patients must have no history of bleeding diathesis or coagulopathy.
- All patients must have a documented BP with systolic < 150 and diastolic < 90 within 28
days of registration. Patients with known hypertension must be on a stable regimen of antihypertensive therapy.
- Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents
(NSAIDS) are eligible. Treatment with dipyridamole (Persantine), ticlopine (Ticlid),
clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed. Patients must have stopped
taking any of these agents at least 7 days prior to randomization.
- 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 intra abdominal abscess within 28 days prior to randomization.
- Patients must not have any anticipated major surgical procedure(s) during the course of the
- 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 entry criteria 3.8. Caution must be exercised for patients requiring anticoagulation,
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.
- 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.
- Pemetrexed/Cisplatin Therapy
- Patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria.
- Patients assigned to pemetrexed/Cisplatin therapy must NOT have squamous cell
- Calculated Creatinine Clearance must be obtained within 2 weeks of randomization
and calculated CrCl must be > 45mL/min using the standard Cockcroft and Gault
formula (See Appendix XIII), or the measured glomerular filtration rate (GFR) using
the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to
calculate CrCl .
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Date Last Changed:
July 22, 2013
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