Neoadjuvant chemoteraphy in unresectable ovarian cancer with olaparib and weekly carboplatin plus paclitaxel: a phase II, open label multicenter study (NUVOLA trial).

BACKGROUND

Neoadjuvant chemotherapy with interval debulking surgery represents an alternative treatment for advanced ovarian cancer. Currently, there are few data about the use of poly adenosine diphosphate-ribose polymerase inhibitors in the neoadjuvant setting.

PRIMARY OBJECTIVE

To evaluate whether the administration of olaparib in combination with standard chemotherapy in the neoadjuvant setting can improve tumor response.

STUDY HYPOTHESIS

The addition of a poly adenosine diphosphate-ribose polymerase inhibitor to standard chemotherapy will achieve a higher response rate in BRCA mutated patients compared with standard chemotherapy TRIAL DESIGN: This is a multicenter, phase II, single arm, open label trial. Eligible patients will receive three cycles of weekly carboplatin plus paclitaxel, and intermittent olaparib administration. Responding patients will undergo an interval debulking surgery with pathological evaluation of response to chemotherapy.

MAJOR ELIGIBILITY CRITERIA

Patients must have histologically confirmed International Federation of Gynecology and Obstetrics stages III-IV primary ovarian, peritoneal, or fallopian tube cancers, high grade serous or endometrioid histology, not suitable for primary cytoreductive surgery with a documented BRCA1 or BRCA2 germline and/or somatic mutation.

PRIMARY ENDPOINT

Rate of complete pathological response after three cycles of the experimental chemotherapy regimen.

SAMPLE SIZE

A total of 35 patients will be enrolled in the study.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS

Expected complete 42 accrual in January 2022, with presentation of results by June 2022.

TRIAL REGISTRATION NUMBER

NCT04261465.