Study on Using Olaparib Alone or with Cediranib Compared to Standard Chemotherapy for Women with Certain Types of Ovarian Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02446600

This clinical trial is testing whether the drug Olaparib, alone or combined with Cediranib, is more effective than standard chemotherapy for women with ovarian, fallopian tube, or primary peritoneal cancer that has returned and is sensitive to platinum-based treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of Olaparib, either alone or combined with Cediranib, against standard chemotherapy in treating women with ovarian, fallopian tube, or primary peritoneal cancer that has returned and responds to platinum-based treatments. Olaparib and Cediranib may help stop cancer growth by blocking certain enzymes and blood vessels needed for tumors to grow. The study aims to find out if these drugs can work better than traditional chemotherapy drugs like carboplatin and paclitaxel.

Description

This study is divided into three treatment groups:

  • Group 1: Patients receive standard chemotherapy, which may include drugs like paclitaxel, carboplatin, gemcitabine, or pegylated liposomal doxorubicin. These drugs are given through an IV and the treatment cycles repeat every 21 or 28 days, depending on the regimen, for at least four cycles.

  • Group 2: Patients take Olaparib pills twice a day. Treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable.

  • Group 3: Patients take Olaparib pills twice a day and Cediranib pills once a day. Treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable.

Throughout the study, patients will undergo various tests, including heart scans, CT or MRI scans, and blood tests, to monitor their health and the effectiveness of the treatment. After completing the study treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Women with ovarian, fallopian tube, or primary peritoneal cancer that has returned and is sensitive to platinum-based treatments.
  • Must have a specific type of cancer, such as high-grade serous or endometrioid cancer, or have a BRCA1 or BRCA2 mutation.
  • Cancer must not have returned for at least six months after the last platinum-based treatment.
  • Must have had a complete response to previous platinum-based treatment.
  • Must be able to swallow pills and have normal organ function as shown by blood tests.
  • Must be willing to use effective birth control during the study and for six weeks after stopping Cediranib.
  • Must be 18 years or older.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within the last four weeks.
  • Participation in another clinical trial within the last four weeks.
  • Previous treatment with a PARP inhibitor or certain other cancer drugs.
  • Untreated or symptomatic brain metastases.
  • History of severe allergic reactions to similar drugs.
  • Serious medical conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • HIV-positive individuals due to potential drug interactions.
  • Use of certain herbal or alternative medicines that could interfere with the study drugs.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Cancer Center35233BirminghamAlabama
University of South Alabama Mitchell Cancer Institute36688MobileAlabama
Alaska Women's Cancer Care99508AnchorageAlaska
Providence Alaska Medical Center99508AnchorageAlaska
Arizona Oncology Associates-West Orange Grove85704TucsonArizona
Arizona Oncology Associates-Wilmot85710TucsonArizona
University of Arkansas for Medical Sciences72205Little RockArkansas
PCR Oncology93420Arroyo GrandeCalifornia
Mercy San Juan Medical Center95608CarmichaelCalifornia
Marin Cancer Care Inc94904GreenbraeCalifornia

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