Study:
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non-Small Lung Cancer (NSCLC)
Rationale:
Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more tumor cells. 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 also may stop the growth of tumor cells by blocking blood
flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any
tumor cells that remain after surgery. It is not yet known whether chemotherapy is more
effective with or without bevacizumab in treating non-small cell lung cancer.
Purpose:
This randomized phase III trial is studying chemotherapy and bevacizumab to see how well
they work compared to chemotherapy alone in treating patients with stage IB, stage II, or
stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in
chemotherapy work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) may kill more tumor cells. 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 also may stop the growth of tumor cells by blocking blood flow to the
tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells
that remain after surgery. It is not yet known whether chemotherapy is more effective with
or without bevacizumab in treating non-small cell lung cancer
Study Status: Recruiting
Recruiting:
Bruno R. Bastos 954-659-5705
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
| Condition |
Intervention |
Phase |
Stage IB Non-small Cell Lung Cancer
Stage IIA Non-small Cell Lung Cancer
Stage IIB Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer |
Drug: gemcitabine hydrochloride
Drug: vinorelbine tartrate
Drug: cisplatin
Drug: docetaxel
Drug: pemetrexed disodium
Biological: bevacizumab
Other: questionnaire administration
Other: laboratory biomarker analysis |
Phase 3 |
Verified by
National Cancer Institute (NCI)
March, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00324805
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Florida - Weston
Weston, Florida 33331
United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio 44122
United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
United States
Cleveland Clinic Cancer Center-Strongsville
Strongsville, Ohio 44136
United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio 44691
United States
Heather Wakelee., Principal Investigator