Study on Veliparib with or without Radiation, Carboplatin, and Paclitaxel for Stage III Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01386385
This clinical trial is exploring whether adding the drug veliparib to standard treatments like radiation, carboplatin, and paclitaxel can improve outcomes for patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Patient Parameters
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Program Overview
The study aims to find out if the drug veliparib, when combined with radiation therapy and chemotherapy drugs carboplatin and paclitaxel, can better treat stage III non-small cell lung cancer that cannot be surgically removed. Veliparib may help stop tumor growth by blocking certain enzymes. Radiation uses high-energy x-rays to kill cancer cells, while carboplatin and paclitaxel work to stop cancer cells from growing and spreading. Researchers want to see if adding veliparib makes these treatments more effective.
Description
This study is divided into two phases. In Phase I, researchers will determine the safest dose of veliparib when used with standard chemotherapy and radiation therapy. In Phase II, they will compare the effectiveness of the treatment with and without veliparib.
During Phase I, patients will receive radiation therapy five days a week for six weeks, along with veliparib taken orally twice a day and chemotherapy drugs carboplatin and paclitaxel given through an IV. If the cancer does not progress, patients will continue with additional treatment cycles.
In Phase II, patients will be randomly assigned to one of two groups. One group will receive the same treatment as in Phase I, while the other group will receive a placebo instead of veliparib, along with the same chemotherapy and radiation therapy.
After completing the study treatment, patients will have follow-up visits every four months for the first two years, then every six months until five years.
Eligibility Criteria
Inclusion Criteria
- Have a new diagnosis of stage IIIA or IIIB non-small cell lung cancer that cannot be removed by surgery.
- Have measurable or non-measurable disease as confirmed by imaging tests.
- No prior treatment for lung cancer, including chemotherapy or radiation.
- No previous surgery to remove the lung tumor, except for diagnostic purposes.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood counts and organ function as determined by specific tests.
- Not be pregnant or nursing, and agree to use effective contraception if of childbearing potential.
- Be able to swallow whole capsules.
- Provide a tumor tissue sample for research purposes.
- Agree to participate in follow-up visits and comply with study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| Tower Cancer Research Foundation | 90211 | Beverly Hills | California |
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