Chemotherapy + Berzosertib for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byAndrea E. Wahner Hendrickson, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and gemcitabine hydrochloride, 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. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving berzosertib with chemotherapy (carboplatin and gemcitabine hydrochloride) may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer compared to chemotherapy alone.

Eligibility Criteria

This trial is for adults with high-grade serous or endometrioid ovarian, peritoneal, or fallopian tube cancer that's metastatic and beyond cure. Participants must have measurable disease, be in their first or second platinum-sensitive recurrence (recurrence >6 months after last platinum therapy), and have adequate organ function. They can't join if they've had more than two prior platinum treatments, recent chemotherapy/radiotherapy, known brain metastases, allergies to the drugs being tested, are pregnant/breastfeeding, or have certain genetic syndromes.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My cancer is a specific type that has spread and cannot be cured with surgery or radiation.

I have a tumor that can be measured with scans or exams.

+12 more

Exclusion Criteria

I will not receive bevacizumab as part of this study's treatment.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

My cancer did not respond to platinum-based treatment or it came back after such treatment.

+8 more

Participant Groups

The trial tests how well patients respond to a combination of Carboplatin and Gemcitabine Hydrochloride with Berzosertib versus standard treatment alone. It aims to find the best dose of these drugs together while assessing side effects when treating recurrent/metastatic ovarian, primary peritoneal or fallopian tube cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin, gemcitabine hydrochloride, VX-970)Experimental Treatment5 Interventions

Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.