Status:
COMPLETED
Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Eli Lilly and Company
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Mono...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of bevacizumab and erlotinib hydrochloride when given together with carboplatin, paclitaxel, and thoracic conformal radiotherapy in patient...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer
- Stage IIIA or IIIB disease
- No malignant pleural or pericardial effusions
- No palpable supraclavicular adenopathy
- Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)
- Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Hemoglobin ≥ 9.0 mg/dL
- Platelet count ≥ 100,000/mm³
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Forced expiratory volume 1 (FEV\_1) ≥ 1 L
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
- Bilirubin normal
- Partial thromboplastin time (PTT) and international normalized ratio (INR) normal
- Urine protein:creatinine ratio \< 1.0
- Blood pressure ≤ 150/100 mm Hg on 3 separate occasions
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant recent hemoptysis (\> ½ teaspoon of bright red blood)
- No unstable angina
- No New York Heart Association (NYHA) congestive heart failure ≥ class II
- No myocardial infarction or stroke within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, non-healing wound, ulcer, or bone fracture
- No thrombosis requiring therapeutic anticoagulation
- No significant traumatic injury within the last 28 days
- PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery
- At least 4 weeks since prior and no concurrent participation in another experimental drug study
- At least 4 weeks since prior and no concurrent major surgical procedure or open biopsy
- At least 2 weeks since prior mediastinoscopy or mediastinotomy
- At least 1 week since prior fine needle aspirations or core biopsies
- No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00280150
Start Date
January 1 2006
End Date
January 1 2013
Last Update
June 19 2017
Active Locations (3)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
2
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
3
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096