A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With 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: etoposide

• Registration Number: NCT00776698
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	Throughout Study

Secondary Outcome Measures

Name	Time	Method
AEs, laboratory parameters	Throughout Study
Tumor response	Throughout Study