Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Recurrent Uterine Corpus Carcinoma

In brief

This phase II trial is studying how well selumetinib works in treating patients with recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01011933

Run by

National Cancer Institute (NCI)

People needed

54

Starts

2009-09-01

Expected to finish

2016-01-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed* endometrial epithelial carcinoma, including any of the following cell types:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• Mesonephric carcinoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 lesion that can be measured in ≥ 1 dimension (longest dimension to be recorded)
• Each lesion must be ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm when measured by spiral CT scan
• Must have ≥ 1 target lesion to be used to assess response, as defined by RECIST criteria
• Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy
• Must have received 1 prior chemotherapeutic regimen for the management of endometrial carcinoma
• Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is considered a systemic chemotherapy regimen
• Not eligible for a higher priority GOG protocol, if one exists (e.g., any active phase III GOG protocol for the same patient population)
• No prior or concurrent CNS disease (treated or untreated) by physical examination, including primary brain tumor or brain metastases
• GOG performance status (PS) 0-2 (for patients who received 1 prior treatment regimen)
• GOG PS 0-1 (for patients who received 2 prior treatment regimens)
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Saint Vincent Oncology Center — Indianapolis, Indiana, United States
• Medical Oncology and Hematology Associates-West Des Moines — Clive, Iowa, United States
• Mercy Cancer Center-West Lakes — Clive, Iowa, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Iowa-Wide Oncology Research Coalition NCORP — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Laurel — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Iowa Lutheran Hospital — Des Moines, Iowa, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Methodist West Hospital — West Des Moines, Iowa, United States
• Mercy Medical Center-West Lakes — West Des Moines, Iowa, United States
• Menorah Medical Center — Overland Park, Kansas, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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