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Treatment Study for Patients with Recurrent, Refractory, or Metastatic Endometrial Cancer

Clinical Trial Title: 
A randomized phase II study comparing single-agent olaparib, single agent cediranib, and the combination of cediranib/olaparib in women with recurrent, persistent or metastatic endometrial cancer.
Clinical Trial Protocol ID: 
18111501
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required. Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.). Note: clear cell histology is excluded
  • Have evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or non-measurable (detectable) disease.
  • Have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen.
  • Have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen.

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

  • Have prior enrollment into a clinical trial including cediranib or olaparib. Note: prior bevacizumab is not an exclusion criterion.
  • Have had prior chemotherapy, endocrine therapy, radiotherapy, or investigational agents within 4 weeks.
  • Have current signs/symptoms of bowel obstruction and/or signs/symptoms of bowel obstruction within the preceding 3 months.
  • Have a history of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula.

This is a partial list of inclusion and exclusion criteria.

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