A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

July 9, 2014 updated by: Hoffmann-La Roche

An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • Spain
      • Castellon, Spain, 12002
      • Madrid, Spain, 28935
      • Madrid, Spain, 28036
      • Malaga, Spain, 29010
      • Palencia, Spain, 34005
      • Valencia, Spain, 46017
      • Valladolid, Spain, 47005
      • Valladolid, Spain, 47010
      • Zamora, Spain, 49021
    • Cadiz
      • Cádiz, Cadiz, Spain, 11009
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
    • Valencia
      • Sagunto, Valencia, Spain, 46520

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.
  • Stage IIIb or IV non-small cell lung cancer.
  • Chemotherapy-naive.

Exclusion Criteria:

  • Previous treatment for non-small cell lung cancer.
  • Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
  • Recent or current chronic treatment with aspirin (> 325 mg/day).

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: Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Names:
  • Avastin
Drug: Cisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
Drug: Docetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Baseline to the end of the study (up to 4 years)
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Baseline to the end of the study (up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Objective Response
Time Frame: Baseline to the end of the study (up to 4 years)
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Baseline to the end of the study (up to 4 years)
Duration of the Objective Response
Time Frame: Baseline to the end of the study (up to 4 years)
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Baseline to the end of the study (up to 4 years)
Overall Survival
Time Frame: Baseline to the end of the study (up to 4 years)
Overall survival is defined as the time from the first dose of study medication until death.
Baseline to the end of the study (up to 4 years)
1-year Survival
Time Frame: Baseline to 1 year
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Baseline to 1 year

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

July 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20081
  • 2006-005619-88 (EudraCT Number)

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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