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Treatment Study for Patients with Ovarian, Fallopian Tube or Peritoneal Cancer

Clinical Trial Title: 
Phase II/III study of the combination of cediranib maleate and olaparib compared to cediranib or olaparib alone or standard of care chemo in patients with recurrent platinum-resistant or -refractory ovarian, fallopian tube or primary peritoneal cancer.
Clinical Trial Protocol ID: 
16092607
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

This randomized trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating women with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and Olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a confirmed diagnosis of serous or endometrioid ovarian, fallopian tube or peritoneal cancer.
  • Have recurrent platinum-resistant or platinum-refractory disease.
  • Have adequate organ and bone marrow function.
  • Are able to swallow pills.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had chemotherapy or radiotherapy within 4 weeks of starting treatment.
  • Have been treated with more than 3 prior treatment regimens.
  • Have received prior treatment with any other investigational agents or prior use of PARP-inhibitors (such as olaparib, veliparib or naraparib).
  • Have uncontrolled intercurrent illness, such as on ongoing  or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with any study requirements.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-7254 or (312) 942-2417
Contact Name: 
Judith Dybinski or Lois Winkelman