This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 groups. GROUP 1: Patients receive cisplatin intravenously (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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Given IV
Given IV
Given IV
Given IV
Given SC
Given SC
Undergo thoracic radiotherapy
Providence Hospital
Mobile, Alabama, United States
Saint Bernards Regional Medical Center
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Adverse Events
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to one year
Progression-free Survival
From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Every week, up to 4 years
Response Rate (Confirmed or Unconfirmed Partial Response)
Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Time frame: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration
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Fremont - Rideout Cancer Center
Marysville, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
...and 53 more locations