Adjuvant Oral Decitabine and Tetrahydrouridine With or Without Celecoxib in People Undergoing Pulmonary Metastasectomy

Summary

Background: Most patients who have surgery for cancer that has metastasized (spread) to the lungs later get more metastases that cannot be treated with surgery or chemotherapy. The drug resistance may be due to DNA changes in cancer cells that activate some genes and turn others off. Researchers want to test a combination of drugs for people with metasteses. Decitabine (DAC) may reverse the DNA changes. Tetrahydrouridine (THU) makes DAC last longer. Celecoxib may slow the progression of cancer. Objectives: To determine a safe dose of DAC and THU by mouth. To see if DAC-THU with or without celecoxib reactivates genes in lung metastases. Eligibility: Adults 18 years and older, with cancer in both lungs that can be treated with surgery. Design: Participants will be screened with: Blood, lung, and heart tests Scans Tests for viruses Pregnancy test Participants will have blood and stool tests. They will have surgery to remove metasteses in 1 lung. About 3 weeks later, they will have lung scans. If the disease is not back, participants will get DAC and THU with or without celecoxib, by mouth for 6 weeks. Participants will have more scans. If the disease is not worse, they will continue the study drugs for 4 more weeks. Participants will have more scans and heart and lung tests. They will have surgery to remove metasteses from the other lung. Participants will have weekly blood and urine tests, plus several blood draws the first 2 days of taking the drugs. Participants will have exams and blood tests before each surgery. Participants will have follow-up visits 1 and 3 months after the second surgery.

Timeline

Start

2016-07-07

Primary completion

2017-04-26

Completion

2017-04-26

Drugs

Indications