A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is <3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is <100 individuals.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- adult patients, >= 18 years of age;
- non-squamous non-small cell lung cancer, locally advanced and unresectable;
- ECOG performance status 0 or 1;
- no prior thoracic or head and neck radiation;
- no prior surgical resection for current lung cancer.
Exclusion criteria
- malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
- prior systemic therapy for non-small cell lung cancer;
- clinically significant cardiovascular disease;
- history of >= grade 2 hemoptysis;
- current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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