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

NCT ID: NCT00776698

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

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).

cisplatin

Intervention Type DRUG

80mg/m2 iv every 3 weeks for 3 cycles

etoposide

Intervention Type DRUG

100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

Interventions

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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).

Intervention Type DRUG

cisplatin

80mg/m2 iv every 3 weeks for 3 cycles

Intervention Type DRUG

etoposide

100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Amsterdam, , Netherlands

Site Status

Groningen, , Netherlands

Site Status

Maastricht, , Netherlands

Site Status

Aberdeen, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Other Identifiers

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2008-002279-28

Identifier Type: -

Identifier Source: secondary_id

BO21563

Identifier Type: -

Identifier Source: org_study_id