Extract

Background: Chemotherapy damages cancer cell DNA so the cells die and the tumor shrinks. But it may stop working in some people over time. This is partly due to efficient DNA damage repair mechanisms used by tumor cells. VX-970 may stop cancer cells from preventing the repair of DNA damaged by chemotherapy. The purpose of this study is to see if using the chemotherapy drug topotecan along with the drug VX-970 will improve the response to chemotherapy. Objective: To study the safety and efficacy of VX-970 and topotecan in treating small cell lung cancer. Eligibility: Adults at least 18 years old with small cell lung cancer . Design: Participants will be screened with medical history, physical exam, blood and heart tests, and scans. Most of these tests are part of their routine care. Most of these tests will be repeated throughout the study. The study is set in 21-day cycles. Participants will get topotecan IV on days 1 through 5. They will get VX-970 IV on day 5 alone or on day 5 and day 2. Participants doctors will monitor them weekly for the first cycle, every 3 weeks after that. For Part 1 of this Study the doses of topotecan and VX-970 will be increased (according to the Protocol) to determine the maximum safe dose of the combination. The maximum safe dose of the combination is the dose at which no more than 1 in 6 people have an intolerable side effect. More participants will join in Phase 2. They will take the drugs at the maximum safe dose, on the same schedule as the drugs were taken in Phase 1. Participants will give samples of blood, hair, and tumor tissue (optional) at different times. They will discuss side effects at every visit. A month after stopping taking the drugs, participants will have a physical exam and blood drawn. They will have follow-up phone calls every 3 months.

Inclusion criteria

• Carcinoma, Non-Small-Cell Lung,Ovarian Neoplasms,Small Cell Lung Carcinoma,Uterine Cervical Neoplasms,Carcinoma, Neuroendocrine

Links

• ictrp
• nct