NCT00369551|TerminatedPhase 1

Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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8 other identifiers

NCI-2012-02718UCCRC-14576ACDR0000491998NCI-721314576A7213P30CA014599N01CM62201

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2006

StartedJun 2006

Brief Summary

This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Last Updated

March 6, 2014

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

August 24, 2006

Last Update Submit

March 5, 2014

Conditions

Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

Safety and feasibility
Up to 36 months
In-field toxicity, defined as bleeding or perforation of the tracheobronchial or gastrointestinal structures within the radiation field
Up to 36 months
Clinical response
Up to 36 months
Correlation of levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response
Up to 36 months

Study Arms (1)

Treatment (paclitaxel, carboplatin, bevacizumab, radiation)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1. Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Radiation: 3-dimensional conformal radiation therapyDrug: paclitaxelBiological: bevacizumabDrug: carboplatinOther: laboratory biomarker analysis