A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Cisplatin; Etoposide; Etoposide phosphate

Criteria

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.