A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.

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ClinicalTrials.gov Identifier: NCT00776698

Recruitment Status : Completed

First Posted : October 21, 2008

Last Update Posted : November 2, 2016

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is <3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is <100 individuals.

Condition or disease	Intervention/treatment	Phase
Non-Squamous Non-Small Cell Lung Cancer	Drug: bevacizumab [Avastin] Drug: cisplatin Drug: etoposide	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.
Study Start Date :	April 2009
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

Drug Information available for: Etoposide Bevacizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: bevacizumab [Avastin] 7.5mg/kg every 3 weeks for 3 cycles (cohort 1) or 15mg/kg every 3 weeks for 3 cycles (cohort 2). Preferred dose every 3 weeks for 9 cycles (cohort 3). Drug: cisplatin 80mg/m2 iv every 3 weeks for 3 cycles Drug: etoposide 100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

Outcome Measures

Primary Outcome Measures :

Dose limiting toxicity [ Time Frame: Throughout Study ]

Secondary Outcome Measures :

AEs, laboratory parameters [ Time Frame: Throughout Study ]
Tumor response [ Time Frame: Throughout Study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >= 18 years of age;
non-squamous non-small cell lung cancer, locally advanced and unresectable;
ECOG performance status 0 or 1;
no prior thoracic or head and neck radiation;
no prior surgical resection for current lung cancer.

Exclusion Criteria:

malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
prior systemic therapy for non-small cell lung cancer;
clinically significant cardiovascular disease;
history of >= grade 2 hemoptysis;
current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776698

Locations

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Netherlands

Amsterdam, Netherlands, 1007 MB

Groningen, Netherlands, 9713 GZ

Maastricht, Netherlands, 6229 HX
United Kingdom

Aberdeen, United Kingdom, AB9 2ZB

Manchester, United Kingdom, M2O 4BX

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

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Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00776698
Other Study ID Numbers:	BO21563 2008-002279-28
First Posted:	October 21, 2008 Key Record Dates
Last Update Posted:	November 2, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:

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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Bevacizumab Etoposide	Antineoplastic Agents Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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