A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
Status and phase
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Treatments
Details and patient eligibility
About
This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
- ECOG performance status of 0 or 1;
- no prior thoracic head and neck irradiation or surgical resection for current lung cancer.
Exclusion criteria
- mixed, non-small cell and small cell tumors;
- mixed adeno-squamous carcinomas with a predominant squamous component;
- evidence of tumor invasion or encasement of major vessels;
- history of grade >=2 hemoptysis;
- presence of cavitations in lung lesions at baseline.
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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