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.

November 1, 2016 updated by: Hoffmann-La Roche

A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M4N 3M5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: bevacizumab [Avastin]
7.5mg/kg iv or 15mg/kg iv every 3 weeks
Drug: cisplatin
75mg/m2 iv according to a standard chemotherapy treatment protocol
Drug: vinorelbine
15mg/m2 iv according to a standard chemotherapy treatment protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response
Time Frame: Week 13 and Week 22
Week 13 and Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO21247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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