Phase Ib with expansion study of olaparib plus weekly (Metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients.
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
BRCA mutation; PARP inhibitor; metronomic chemotherapy; serous ovarian carcinoma
OBJECTIVE: Our goals were to: establish the maximum-tolerated dose of olaparib tablets combined with metronomic carboplatin and paclitaxel in patients with relapsed high-grade serous ovarian cancer; evaluate dose-limiting toxicities; and evaluate efficacy at the maximum tolerated dose.
METHODS: In this open-label, single-arm, investigator-initiated trial (ClinicalTrials.gov NCT01650376), patients with high-grade serous ovarian cancer who failed primary platinum and taxane therapy received oral olaparib tablets twice daily days 1-3 each week combined with fixed-dose metronomic carboplatin AUC2 and paclitaxel 60 mg/m
RESULTS: The maximum tolerated dose of olaparib tablets was 150 mg twice daily with metronomic carboplatin and paclitaxel. 54 women were enrolled, 14 in phase Ib and 40 in the expansion phase. The median number of prior therapeutic regimens was 3. Response included 13 complete remission (24%) and 16 partial remission (30%) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for an overall response rate of 54% (95% CI 40% to 67%). Of 47 patients who underwent
CONCLUSIONS: Olaparib 150 mg tablet twice daily can be safely administered in combination with metronomic carboplatin and paclitaxel in pre-treated relapsed ovarian cancer with 24% complete remission.
TRIAL REGISTRATION NUMBER: NCT01650376.
Women & Children
Obstetrics & Gynecology
Rivkin, Saul Eugene; Moon, James; Iriarte, Desiree S; Bailey, Erik; Sloan, Heather L; Goodman, Gary E; BonDurant, Amy E; Velijovich, Dan; Wahl, Tanya; Jiang, Peter; Shah, Chirag A; Drescher, Charles; Fer, MF; Kaplan, Henry G; and Ellis, Erin D, "Phase Ib with expansion study of olaparib plus weekly (Metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients." (2019). Articles, Abstracts, and Reports. 1064.