Research and Clinical Trials

Title  
CTSU E1505: Phase III Randomized Study of Adjuvant Chemotherapy With or Without Bevacizumab in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Brief Description  
This randomized 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. This project is being conducted at the following locations: Carolinas Medical Center/Blumenthal Cancer Center, Carolinas Hematology-Oncology Associates, and Mecklenburg Medical Group.
Who may be Eligible  

Inclusion Criteria:
  • 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 histolgy (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)

Exclusion Criteria:
  • 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
Speciality/Disorder  
Lung Cancer
IRB Number  
06-08-04B
Principal Investigator  
Pal, Sridhar

For More Information, Contact  Rebecca  , Witkowski
Phone:  (704) 403-1280  Fax:  (704) 403-1517  
Email:  rebecca.witkowski@carolinashealthcare.org
Address:920 Church Street North Concord, NC 28025
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