Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05295589
Phase
PHASE2
Status
Withdrawn

Conditions

  • Platinum-Refractory Fallopian Tube Carcinoma
  • Platinum-Refractory Ovarian Carcinoma
  • Platinum-Refractory Primary Peritoneal Carcinoma
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian High Grade Serous Adenocarcinoma
  • Recurrent Platinum-Resistant Fallopian Tube Carcinoma
  • Recurrent Platinum-Resistant Ovarian Carcinoma
  • Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
  • Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Copanlisib Hydrochloride — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO
  • Paclitaxel — DRUG
    Given IV
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV
  • Topotecan Hydrochloride — DRUG
    Given IV

Study Details

This phase II trial compares copanlisib and olaparib to standard of care chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that did not respond to previous platinum-based chemotherapy (platinum resistant) and that has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and olaparib may extend the time that the cancer does not progress compared to standard of care chemotherapy in patients with recurrent platinum resistant ovarian, fallopian tube, or primary peritoneal cancer.

Key Dates

Start date
Jun 30, 2022
Status verified
Sep 2023
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (standard of care chemotherapy)
    Patients receive either paclitaxel IV OR pegylated liposomal doxorubicin hydrochloride IV, OR topotecan hydrochloride IV while on study. Patients undergo CT scan while on study and may undergo MRI throughout the study.
  • Experimental: Arm II (copanlisib, olaparib)
    Patients receive copanlisib hydrochloride IV and olaparib PO while on study. Patients undergo CT scan while on study and may undergo MRI throughout the study.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Cleveland Clinic FoundationClevelandOhio44195-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Women and Infants HospitalProvidenceRhode Island02905-

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, COUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IACleveland Clinic Foundation· Cleveland, OHUniversity of Oklahoma Health Sciences Center· Oklahoma City, OKWomen and Infants Hospital· Providence, RI

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