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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
7.5mg/kg iv or 15mg/kg iv every 3 weeks
75mg/m2 iv according to a standard chemotherapy treatment protocol
15mg/m2 iv according to a standard chemotherapy treatment protocol
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Oshawa, Ontario, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
Time frame: Throughout study
Tumor response
Time frame: Week 13 and Week 22
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