MedDataX Logo

A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.

NCT ID: NCT00773188

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Squamous Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

7.5mg/kg iv or 15mg/kg iv every 3 weeks

cisplatin

Intervention Type DRUG

75mg/m2 iv according to a standard chemotherapy treatment protocol

vinorelbine

Intervention Type DRUG

15mg/m2 iv according to a standard chemotherapy treatment protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bevacizumab [Avastin]

7.5mg/kg iv or 15mg/kg iv every 3 weeks

Intervention Type DRUG

cisplatin

75mg/m2 iv according to a standard chemotherapy treatment protocol

Intervention Type DRUG

vinorelbine

15mg/m2 iv according to a standard chemotherapy treatment protocol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients \>=18 years with locoregional advanced unresectable non-squamous NSCLC;
* ECOG performance status of 0 or 1;
* no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

Exclusion Criteria

* mixed, non-small cell and small cell tumors;
* mixed adeno-squamous carcinomas with a predominant squamous component;
* evidence of tumor invasion or encasement of major vessels;
* history of grade \>=2 hemoptysis;
* presence of cavitations in lung lesions at baseline.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Calgary, Alberta, Canada

Site Status

Oshawa, Ontario, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BO21247

Identifier Type: -

Identifier Source: org_study_id