!

COVID-19 Response

Access our COVID-19 Response homepage, with more information and resources during the COVID-19 pandemic, including what to do if you’re experiencing symptoms.

Baylor College of Medicine

Phase I/II Study of Niraparib with Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix (H-40404)

Description

Content

The most effective strategy for managing distantly metastatic invasive carcinomas of the cervix is not defined. Based on the success of niraparib in breast and ovarian cancer trials and the concern for toxicities and comorbidities limiting the compliance of concurrent cisplatin for cervical cancer, this study is a phase I/II study of women diagnosed with distantly metastatic (Stage IV) disease to determine the maximum tolerated dose and to evaluate the safety, tolerability and preliminary efficacy of niraparib, an orally available small molecule PARP inhibitor when administered concurrently with definitive regional radiotherapy for treatment of cervical cancer. Women enrolled in this study will receive 3-6 cycles of induction-style carboplatin and paclitaxel followed by definitive doses of pelvic radiotherapy along with the oral niraparib given at the same time.

Contact

Michelle S. Ludwig, M.D., MPH, Ph.D.

Phone 1: 713–724–4440

IRB: H-40404

Status:

Active

Created:

Back to topback-to-top