A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00806923
First received: December 10, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recu rrent non-squamous non-small cell lung cancer (NSCLC) who have not received prio r chemotherapy. The anticipated time of study treatment is until disease progres sion, and the target sample size is 500+ individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Cisplatin
Drug: Gemcitabine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Safety:AEs, laboratory tests, SAEs, coagulation parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1044
Study Start Date: February 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Experimental: 2 Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Placebo Comparator: 3 Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: Placebo
iv on day 1 of each 3 week cycle until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
  • adequate liver and kidney function;
  • women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic cancer therapy;
  • surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
  • brain metastasis or spinal cord compression;
  • fertile men, and women of childbearing potential, not using adequate contraception;
  • treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806923

  Show 154 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00806923     History of Changes
Other Study ID Numbers: BO17704
Study First Received: December 10, 2008
Last Updated: July 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014