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

November 1, 2016 updated by: Hoffmann-La Roche

An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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

  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
      • Groningen, Netherlands, 9713 GZ
      • Maastricht, Netherlands, 6229 HX
  • United Kingdom
      • Aberdeen, United Kingdom, AB9 2ZB
      • Manchester, United Kingdom, M2O 4BX

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:

  • 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.

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 every 3 weeks for 3 cycles (cohort 1) or 15mg/kg every 3 weeks for 3 cycles (cohort 2). Preferred dose every 3 weeks for 9 cycles (cohort 3).
Drug: cisplatin
80mg/m2 iv every 3 weeks for 3 cycles
Drug: etoposide
100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose limiting toxicity
Time Frame: Throughout Study
Throughout Study

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters
Time Frame: Throughout Study
Throughout Study
Tumor response
Time Frame: Throughout Study
Throughout Study

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

April 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 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

  • BO21563
  • 2008-002279-28

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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