Study on Veliparib with or without Radiation, Carboplatin, and Paclitaxel for Stage III Non-Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Anchorage Associates in Radiation Medicine98508AnchorageAlaska
Alaska Breast Care and Surgery LLC99508AnchorageAlaska
Alaska Oncology and Hematology LLC99508AnchorageAlaska
Alaska Women's Cancer Care99508AnchorageAlaska
Anchorage Oncology Centre99508AnchorageAlaska
Katmai Oncology Group99508AnchorageAlaska
Providence Alaska Medical Center99508AnchorageAlaska
Banner University Medical Center - Tucson85719TucsonArizona
University of Arizona Cancer Center-North Campus85719TucsonArizona
Tower Cancer Research Foundation90211Beverly HillsCalifornia

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