Study on Gemcitabine with or without WEE1 Inhibitor MK-1775 for Treating Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02101775

This clinical trial is testing whether adding a new drug, WEE1 inhibitor MK-1775, to the standard chemotherapy drug gemcitabine can improve treatment for patients with ovarian, primary peritoneal, or fallopian tube cancer that has returned after treatment.

Patient Parameters

Parameter	Options

Program Overview

The study aims to find out if combining gemcitabine, a chemotherapy drug, with a new drug called WEE1 inhibitor MK-1775, is more effective than using gemcitabine alone for treating ovarian, primary peritoneal, or fallopian tube cancer that has come back. Gemcitabine works by damaging the DNA of cancer cells, stopping them from growing. The WEE1 protein helps repair these damaged cells, allowing the tumor to grow. The WEE1 inhibitor MK-1775 may block this repair process, potentially making gemcitabine more effective without harming normal cells.

Description

The main goal of this study is to see if the combination of gemcitabine and WEE1 inhibitor MK-1775 can help patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer live longer without the disease getting worse. Researchers will also look at how well the tumors respond to the treatment, the overall survival of patients, and the safety of the drug combination. They will also study specific genetic factors that might predict how well patients respond to the treatment.

Participants will be randomly assigned to one of two groups. One group will receive the WEE1 inhibitor MK-1775 along with gemcitabine, while the other group will receive a placebo with gemcitabine. Both groups will receive treatment in cycles of 28 days, as long as the cancer does not progress or side effects are manageable. After completing the treatment, patients will have follow-up visits every 6-8 weeks for up to a year.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Cancer must be resistant to platinum-based treatments or have returned after such treatments.
Have measurable disease that can be tracked using scans or exams.
No limit on the number of previous treatments received.
Must have completed any prior treatments at least 4 weeks before starting the study.
Be in good overall health with a performance status score of 0 to 2.
Have a life expectancy of more than 3 months.
Meet specific blood count and organ function criteria.
Be able to take oral medication and not have active bowel obstruction.
Agree to undergo biopsies for research purposes.
Women of childbearing potential must use effective contraception during the study.

Exclusion Criteria

Have previously received gemcitabine for recurrent cancer.
Are taking other investigational drugs.
Have unstable brain metastases.
Have allergies to similar drugs as those used in the study.
Are taking certain medications that interact with the study drugs.
Are pregnant or breastfeeding.
Have HIV and are on antiretroviral therapy.
Have uncontrolled illnesses such as recent heart attack, heart failure, severe infections, or psychiatric conditions that would interfere with the study.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Comprehensive Cancer Center	91010	Duarte	California
City of Hope South Pasadena	91030	South Pasadena	California
University of Chicago Comprehensive Cancer Center	60637	Chicago	Illinois
Decatur Memorial Hospital	62526	Decatur	Illinois
Indiana University/Melvin and Bren Simon Cancer Center	46202	Indianapolis	Indiana
Mayo Clinic in Rochester	55905	Rochester	Minnesota
Fox Chase Cancer Center	19111	Philadelphia	Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)	15232	Pittsburgh	Pennsylvania

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