Cediranib + Olaparib for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen ByJoyce Liu, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is evaluating whether a drug called olaparib and a drug called cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).

Eligibility Criteria

This trial is for adults with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Participants must have measurable disease and not have used PARP inhibitors before. They should be in good physical condition (ECOG <=2) and able to take oral medications. Those with controlled blood pressure, no recent chemotherapy or invasive cancers (with some exceptions), and no history of certain heart conditions can join.

Inclusion Criteria

My thyroid function is normal, with no symptoms of dysfunction.

My cancer did not worsen within 6 months after my last platinum-based treatment.

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

My kidney function is within the normal range.

I am willing to have biopsies before and during treatment.

I am 18 years old or older.

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

Exclusion Criteria

I have not used PARP inhibitors or drugs affecting the VEGF pathway for my cancer.

Criterion: You have had a heart attack, unstable chest pain, or severe heart failure in the last six months. You have also had specific cancer treatments or surgeries within certain timeframes, or are currently dealing with certain medical conditions or medications.

I have never had a hypertensive crisis or brain issues due to high blood pressure.

I am not pregnant or breastfeeding.

Participant Groups

The study tests the effectiveness of combining Cediranib Maleate and Olaparib in treating patients whose ovarian cancer has returned after treatment. It examines if these drugs can block enzymes needed for tumor growth, using imaging techniques like CT scans and MRIs to measure results.

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib and cediranib maleate)Experimental Treatment9 Interventions

Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy of tumor, blood sample collection, MUGA or echocardiogram, and CT scan or MRI scan throughout the study.