A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
I. Determine the frequency and severity of toxic effects of induction therapy comprising
cisplatin, etoposide, and radiotherapy with or without bevacizumab followed by consolidation
therapy comprising docetaxel and bevacizumab, in terms of grade 4 or 5 hemorrhage, in
patients with newly diagnosed, unresectable, stage III non-small cell lung cancer.
I. Determine progression-free and overall survival of patients treated with these regimens.
II. Determine response (confirmed, unconfirmed, partial, and complete) in patients with
measurable disease treated with these regimens.
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to risk
(high* vs low).
NOTE: *High-risk stratum closed to accrual as of 2/20/09.
INDUCTION THERAPY: Patients in each stratum are assigned to 1 of 3 sequential treatment
GROUP 1: Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV
over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
GROUP 2: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1.
Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
GROUP 3: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1.
Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.
CONSOLIDATION CHEMOTHERAPY: Beginning 3-6 weeks after completion of induction therapy, all
patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and
bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SC) beginning on day 2 and continuing until blood counts recover OR
pegfilgrastim SC once on day 2.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. After completion of study treatment, patients are followed
periodically for up to 4 years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grade 4 or higher hemorrhage
Up to 1 year
Southwest Oncology Group
United States: Food and Drug Administration
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Loyola University Medical Center||Maywood, Illinois 60153|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Salina Regional Health Center||Salina, Kansas 67401|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Denver Health Medical Center||Denver, Colorado 80204-4507|
|Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|Providence Hospital||Mobile, Alabama 36608|
|Tahoe Forest Cancer Center||Truckee, California 96161|
|University of Rochester||Rochester, New York 14642|
|Wayne State University||Detroit, Michigan 48202|
|Valley View Hospital Cancer Center||Glenwood Springs, Colorado 81601|
|Hays Medical Center||Hays, Kansas 67601|
|Highlands Oncology Group-Bentonville||Bentonville, Arkansas 72712|
|Northbay Cancer Center||Fairfield, California 94533|
|Fremont - Rideout Cancer Center||Marysville, California 95901|
|Cancer Centers of Central Florida PA||Leesburg, Florida 34788|
|Saint Francis Hospital and Medical Center - Topeka||Topeka, Kansas 66606|
|Highland Clinic||Shreveport, Louisiana 71105|
|Kansas City Veterans Affairs Medical Center||Kansas City, Missouri 64128|
|Highland Hospital||Rochester, New York 14620|
|Audie L Murphy Veterans Affairs Hospital||San Antonio, Texas 78209|
|University Hospital||San Antonio, Texas 78229|
|Olathe Cancer Center||Olathe, Kansas 66061|
|University of Colorado Cancer Center - Anschutz Cancer Pavilion||Aurora, Colorado 80045|
|Denver Veterans Administration Medical Center||Denver, Colorado 80220|
|The Shaw Regional Cancer Center||Edwards, Colorado 81632|
|Montrose Memorial Hospital||Montrose, Colorado 81401|
|Saint Bernards Regional Medical Center||Jonesboro, Arkansas 72401|
|Mount Clemens Regional Medical Center||Mount Clemens, Michigan 48043|
|Arnot Ogden Medical Center||Elmira, New York 14905|
|University of Tennessee - Memphis||Memphis, Tennessee 38163|
|Southwest Oncology Group||San Antonio, Texas 78245|
|Edward Hospital/Cancer Center||Naperville, Illinois 60540|
|Promise Regional Medical Center-Hutchinson||Hutchinson, Kansas 65702|
|Portland Veterans Administration Medical Center||Portland, Oregon 97239|