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

Int J Gynecol Cancer. 2021 Aug;31(8):1175-1178. doi: 10.1136/ijgc-2021-002727. Epub 2021 Jun 15.

Abstract

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.

Keywords: BRCA1 protein; BRCA2 protein; ovarian cancer; ovarian neoplasms.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / pharmacology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / pharmacology
  • Carboplatin / therapeutic use*
  • Female
  • Humans
  • Neoadjuvant Therapy
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / mortality
  • Paclitaxel / pharmacology
  • Paclitaxel / therapeutic use*
  • Phthalazines / pharmacology
  • Phthalazines / therapeutic use*
  • Piperazines / pharmacology
  • Piperazines / therapeutic use*
  • Survival Analysis

Substances

  • Phthalazines
  • Piperazines
  • Carboplatin
  • Paclitaxel
  • olaparib

Associated data

  • ClinicalTrials.gov/NCT04261465