Phase I Study of Talazoparib in Combination With Radiation Therapy for Locally Recurrent Gynecologic Cancers
M.D. Anderson Cancer Center
Summary
This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.
Description
PRIMARY OBJECTIVE: I. To determine the safety, tolerability, and maximally tolerated dose (MTD) of talazoparib combining talazoparib and fractionated radiotherapy in patients with refractory or recurrent ovarian, fallopian tube, primary peritoneal, cervical, or vaginal or endometrial carcinoma. SECONDARY OBJECTIVES: I. To determine the safety profile of talazoparib in combination with fractionated radiotherapy for recurrent gynecologic cancers. II. To determine a preliminary anti-cancer activity of this combination at the MTD. EXPLORATORY OBJECTIVES: I. To explore the potential feasibili…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis * Subjects with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy \[RT\]) is undetectable or stable (\>= 3 months) and immediate chemotherapy is not required. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least…
Interventions
- OtherQuality-of-Life Assessment
Ancillary studies
- RadiationRadiation Therapy
Undergo radiation therapy
- DrugTalazoparib
Given PO
Locations (2)
- Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, Maryland
- M D Anderson Cancer CenterHouston, Texas