A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

August 23, 2016 updated by: Hoffmann-La Roche

An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

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

  • Australia
      • Tugun, Australia
      • Wollongong, Australia
  • Belgium
      • Liege, Belgium
  • Czech Republic
      • Ostrava, Czech Republic
      • Usti nad Labem, Czech Republic
  • France
      • Bobigny, France
      • Marseille, France
      • Nantes, France
  • Hungary
      • Szekesfehervar, Hungary
      • Szombathely, Hungary
  • Israel
      • Kfar Saba, Israel
      • Ramat Gan, Israel
  • Poland
      • Lublin, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Russian Federation
      • Balashikha, Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Spain
      • Madrid, Spain
      • Sevilla, Spain
  • Taiwan
      • Kueishan, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan

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;
  • documented squamous non-small cell lung cancer;
  • stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;
  • suitable for platinum-based treatment as first line chemotherapy.

Exclusion Criteria:

  • prior systemic anti-tumor therapy;
  • prior radiotherapy for treatment of patient's current stage of disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.

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: Platinum-based chemotherapy
As prescribed
Drug: bevacizumab [Avastin]
15mg iv on day 1 of each 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of grade >=3 Avastin-related pulmonary hemorrhage
Time Frame: After a maximum of 12 months treatment
After a maximum of 12 months treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response, duration of response, progression-free survival.
Time Frame: Event driven
Event driven
AEs, laboratory parameters, coagulation parameters.
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

August 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO19734

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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