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Therapeutic Areas: Oncology
Disease Category: Lung Cancer

Trial Information

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.

DISEASE CHARACTERISTICS:

• Diagnosis of stage IB-IIIA (T2-3 N0, T1-3 N1, T1-3 N3) non-small cell lung cancer (NSCLC)
• Patients with stage IB disease must have tumors measuring ≥ 4 cm
• No non-squamous cell histology (for patient assigned to receive the pemetrexed disodium and cisplatin therapy)
• Must have undergone complete resection of NSCLC within the past 6-12 weeks
• Accepted types of resection include any of the following:
  • Lobectomy
  • Sleeve lobectomy
  • Bilobectomy
  • Pneumonectomy
  • No resection by segmentectomy or wedge resection
  • Mediastinal lymph node sampling at specific levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 for right-sided tumors or level 7 and 5 and/or 6 for left sided tumors)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• INR ≤ 1.5 OR INR ≤ 3.0 with therapeutic anticoagulation
• PTT normal
• Bilirubin ≥ 1.5 mg/dL
• AST and ALT < 5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance = 45 mL/min (for patient assigned to receive the pemetrexed disodium and cisplatin therapy)
• If urine protein:creatinine ratio > 0.5, then urine protein must be < 1,000 mg by 24-hour urine collection
• No other cancer within the past 5 years except in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer
• Known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) allowed if there is no evidence of active disease within the past 12 months
• No history of cerebrovascular accident or transient ischemic attack
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
• No clinically significant ongoing, active, or serious infection, symptomatic or uncontrolled congestive heart failure or cardiac arrhythmia, psychiatric illness or social situation, or any other medical condition that would preclude study compliance
• No history of bleeding diathesis or coagulopathy
• No uncontrolled hypertension
• Hypertension allowed if well controlled (i.e., blood pressure < 150/90 mmHg) on a stable regimen of antihypertensive therapy
• No serious nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No ongoing postoperative hemoptysis (i.e., bright red blood of ≥ ½ teaspoon

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery
• At least 7 days since prior aspirin or non-steroidal anti-inflammatory agents (NSAIDS), dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal)
• No prior systemic chemotherapy
• No hormonal cancer therapy or radiotherapy as cancer treatment within the past 5 years
• Prior surgery, biologic therapy, hormonal therapy, or radiotherapy for a malignancy diagnosed > 5 years prior to study entry that is now considered cured allowed
• No major surgery or open biopsy within the past 28 days
• No anticipated major surgery during course of treatment
• No core biopsy within the past 7 days
• Concurrent therapeutic anticoagulation therapy allowed
• No concurrent aminoglycoside antibiotics
• No concurrent growth factors

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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