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.

Phase 1

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: bevacizumab [Avastin]; Drug: cisplatin; Drug: vinorelbine

• Registration Number: NCT00773188
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Study Start: 2008-12
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	bevacizumab [Avastin]	-
1	cisplatin	-
1	vinorelbine	-

Primary Outcome Measures

Name	Time	Method
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.	Throughout study

Secondary Outcome Measures

Name	Time	Method
Tumor response	Week 13 and Week 22