Swedish Medical Center Seattle - CRC 11114: Rivkin AZ ovarian

CRC 11114: Phase Ib with Expansion of Patients at the MTD Study of Olaparib plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients

Type of Study

Cancer (Oncology) - Ovarian

Location

Short Description

Purpose: The purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.

Status

Open to Enrollment

Principal Investigator

Saul Rivkin, M.D.

Eligibility Notes

Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:
- Platinum sensitive: relapsed at least 6 months following platinum treatment
- Platinum refractory: the cancer grew while on platinum treatment
- Platinum resistant: recurrence within 6 months of platinum treatment
Must have failed first line treatment
ECOG performance status 0-2
Must be able to swallow and retain oral medication
No previous treatment with a PARP inhibitor, including olaparib
No systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)
Must not be currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors
No known active hepatic disease (i.e. Hepatitis B or C)
No uncontrolled seizures
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel

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