Status:
COMPLETED
Bevacizumab, Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere wi...
Detailed Description
OBJECTIVES: Primary * Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab, cisplatin, etoposide, and radiotherapy. Secondar...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Limited-stage disease, defined as SCLC confined to ≥ 1 of the following:
- One hemithorax
- Ipsilateral supraclavicular fossa
- Measurable disease
- No malignant pleural effusion, contralateral hilar disease, or contralateral supraclavicular disease
- Minimal pleural effusion visible on CT scan of the chest, but not evident on chest x-ray, allowed
- No completely surgically resected disease
- No CNS disease, including primary brain tumor or brain metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine protein \< 1,000 mg
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- INR ≤ 1.5 (unless on full-dose anticoagulants)
- No active serious infection
- No serious or nonhealing wound
- No ulcer or bone fracture
- No evidence of bleeding diatheses or coagulopathy
- No hemoptysis
- No known hypersensitivity to Chinese hamster ovary cell products and/or other recombinant human antibodies
- No clinically significant cardiovascular disease, including any of the following:
- Uncontrolled hypertension
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris
- Symptomatic peripheral vascular disease
- Cerebrovascular accident within the past 6 months
- Symptomatic heart disease within the past 6 months
- Myocardial infarction within the past 6 months
- Unstable angina within the past 6 months
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks
- No significant traumatic injury within the past 4 weeks
- PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior major surgery or open biopsy
- At least 1 week since prior core biopsy
- No prior chemotherapy or radiotherapy for small cell lung cancer
- No concurrent major surgery
- No concurrent palliative local radiotherapy
- No concurrent intensity-modulated radiotherapy
- Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met:
- INR ≤ 3
- In-range INR (2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00387699
Start Date
October 1 2006
End Date
April 1 2014
Last Update
April 28 2015
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