A Phase II Study of Temozolomide Alone or with ABT-888 (Veliparib) in Patients with Relapsed or Refractory Small Cell Lung Cancer

Protocol
12-021
Full Title
A Multi-Center, Randomized, Double-Blind Phase II Study Comparing ABT-888, a PARP Inhibitor, versus Placebo with Temozolomide in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer (NCI Protocol #9026)
Phase
II
Purpose

Temozolomide is a drug used to treat brain cancer. It has shown some activity against small cell lung cancer and is being evaluated as a potential treatment for this disease. ABT-888 (veliparib) is an investigational drug that kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer drugs, such as temozolomide.

The purpose of this study is to evaluate the safety and effectiveness of temozolomide alone and with ABT-888 in patients with small cell lung cancer that has persisted despite, or has returned after, prior chemotherapy. Patients will be randomly assigned to receive temozolomide plus placebo or temozolomide plus ABT-888. Both medications are pills that are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have small cell lung cancer that has continued to grow despite one or two prior regimens of chemotherapy.
  • At least 3 weeks must have passed since completion of prior chemotherapy and radiation therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. M. Catherine Pietanza at 646-888-4203.

Disease(s)
Lung Cancer
Lung Cancer, Small Cell
Lung Cancer, Small Cell: Other
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