Study on Chemotherapy, Radiation, and Bevacizumab for Stage III Non-Small Cell Lung Cancer That Can't Be Removed by Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00334815
This clinical trial is exploring a combination of chemotherapy, radiation therapy, and the drug bevacizumab to treat patients with newly diagnosed stage III non-small cell lung cancer that cannot be surgically removed.
Patient Parameters
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Program Overview
The study aims to find out if combining chemotherapy drugs (cisplatin, etoposide, and docetaxel) with radiation therapy and bevacizumab can effectively treat stage III non-small cell lung cancer that cannot be removed by surgery. Chemotherapy works by stopping cancer cells from growing and spreading, while radiation uses high-energy x-rays to kill cancer cells. Bevacizumab is a monoclonal antibody that may help stop cancer cells from growing by blocking their blood supply. The combination of these treatments may kill more cancer cells.
Description
The main goal of this study is to determine how often and how severe the side effects are when using a combination of chemotherapy (cisplatin, etoposide) and radiation therapy, with or without bevacizumab, followed by additional chemotherapy (docetaxel) and bevacizumab. Researchers are particularly interested in the risk of severe bleeding in patients with newly diagnosed, inoperable stage III non-small cell lung cancer.
The study also aims to measure how long patients live without the cancer getting worse and their overall survival. Additionally, it will assess how well the cancer responds to the treatment.
Patients are divided into groups based on their risk level and receive different treatment schedules:
- Group 1: Receives cisplatin and etoposide with radiation therapy.
- Group 2: Receives the same treatment as Group 1, plus bevacizumab on specific days.
- Group 3: Receives the same treatment as Group 1, plus bevacizumab on different days.
After the initial treatment, all patients receive additional chemotherapy with docetaxel and bevacizumab, along with a medication to help blood cell recovery. This part of the treatment is repeated every 21 days for up to three cycles, as long as the cancer does not progress and side effects are manageable. Patients will be monitored for up to four years after completing the study treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage III non-small cell lung cancer that cannot be removed by surgery.
- Newly diagnosed and confirmed by lab tests.
- Cancer must be in one lung or both, but not more than one lesion in each.
- Must meet specific criteria for stage IIIA or IIIB cancer.
- Must have measurable or non-measurable disease by scans.
- No cancer spread to the brain or other distant organs.
- Must be willing to participate in a lung cancer specimen repository study.
- Must have normal kidney function and adequate blood counts.
- Must not have had a heart attack or stroke in the past six months.
- Must not have uncontrolled high blood pressure or serious heart conditions.
- Must not be pregnant or nursing and must agree to use contraception during and after treatment.
- Must not have had prior chemotherapy or radiation for lung cancer.
- Must not have other serious medical conditions that increase the risk of bleeding.
- Must not have allergies to certain medications used in the study.
- Must not be taking full-dose blood thinners or other cancer treatments concurrently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Hospital | 36608 | Mobile | Alabama |
| Saint Bernards Regional Medical Center | 72401 | Jonesboro | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Fremont - Rideout Cancer Center | 95901 | Marysville | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Providence Santa Rosa Memorial Hospital | 95405 | Santa Rosa | California |
| Gene Upshaw Memorial Tahoe Forest Cancer Center | 96161 | Truckee | California |
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