A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00451906

Purpose

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: bevacizumab [Avastin] Drug: Platinum-based chemotherapy	Phase IV

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label Study of Avastin in Combination With Platinum-Containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-Squamous NSCLC

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of survival; time to disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2012

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 15mg/kg iv on day 1 of each 3 week cycle Drug: Platinum-based chemotherapy As prescribed

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;
histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
ECOG PS status 0-2;
life expectancy >= 12weeks;
adequate renal, liver and hematological function.

Exclusion Criteria:

mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
evidence of tumor invading major blood vessels on imaging;
evidence of CNS metastases, even if previously treated.
major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
prior chemotherapy for stage IIIb/IV disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451906

Show 472 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MO19390
Study First Received:	March 22, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00451906
Health Authority:	Austria: Ministry of Health

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Bevacizumab
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009