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

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 recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, 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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Bevacizumab

U.S. FDA Resources

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

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):

Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. Epub 2011 Jan 18.

Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6.

Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-9. Epub 2010 Feb 11.

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:	August 15, 2012
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 May 19, 2013