A trial to compare chemotherapy + bevacizumab and chemotherapy alone in patients with resected lung cancer (called non-small cell lung cancer)
- Conditions
- Completely Resected Stage IB (=4 cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).MedDRA version: 17.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-003195-19-IE
- Lead Sponsor
- ICORG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1500
1.0 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. (Refer to Appendix X for staging guidelines per AJCC 6th edition). 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-operative (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.
2.0 Patients must be no less than 6 weeks (42 days) and no more (84 days) than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
3.0 Age = 18 years.
4.0 ECOG performance status 0 or 1.
5.0 Patients must not have received the following:
5.1 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.
5.2 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 over 5 years prior to enrollment that is now considered cured is acceptable.)
6.0 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.
7.0 Required laboratory values obtained within two weeks of 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
PTT = institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be = 1.5 x ULN
Total Bilirubin = 1.5 mg/dL
SGOT (AST) < 5 x upper limit of normal (ULN)
SGPT (ALT) < 5 x upper limit of normal (ULN)
8.0 Patients must have adequate renal function as determined by the following tests within 2 weeks prior to randomization:
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 (1g) for patient enrollment.
9.0 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.
10.0 Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial.
11.0 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.
12.0 All patients must have a documented BP
1.0 Patients less than 6 weeks (42 days) and more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
2.0 Age = 18 years.
3.0 Patients who have received the following:
3.1 Prior systemic chemotherapy at any time. (Please refer to principal inclusion criteria 5.1 for exception)
3.2 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 over 5 years prior to enrollment that is now considered cured is acceptable.)
4.0 Patients with 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.
5.0 Required laboratory values not obtained within two weeks of randomization
6.0 Inadequate renal function.
7.0 Evidence of active myocardial infarction or other evidence of arterial thrombotic disease (angina) within 12 months prior to randomization.
8.0 History of cerebral vascular accident (CVA) or transient ischemic attack (TIA).
9.0 Pregnant or breast-feeding women 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 who have not had a blood or urine test within 2 weeks prior to randomization to rule out pregnancy.
10.0 Both fertile men and women not agreeing to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab.
11.0 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.
12.0 History of bleeding diathesis or coagulopathy.
13.0 History of hypertension not well controlled (controlled BP defined as systolic < 150 and diastolic < 90 mm Hg within 28 days of registration) on a stable regimen of anti-hypertensive therapy.
14.0 Treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal). Patients must have stopped taking any of these agents at least 7 days prior to randomization.
15.0 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.
16.0 History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to randomization.
17.0 Anticipated major surgical procedure(s) during the course of the study.
18.0 Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
19.0 Patients with ongoing post-operative hemoptysis (defined as bright red blood of ½ teaspoon or more).
20.0 Patients who will recieve pemetrexed/cisplatin therapy must NOT have squamous cell histology.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method