Gemcitabine 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 the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID

NCT00820898

Run by

Gynecologic Oncology Group

People needed

24

Starts

2009-02-01

Last updated by the study team

2017-12-29

Who can join

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

You may qualify if…

• Histologically confirmed endometrial adenocarcinoma
• Recurrent or persistent disease
• Refractory to curative therapy or established treatments
• The following epithelial cell types are eligible:
• 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
• Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion
• Tumors within a previously irradiated field are designated as target lesions provided there is documented disease progression or biopsy confirmed persistent disease ≥ 90 days after completion of radiotherapy
• Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
• Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
• No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
• One additional non-cytotoxic regimen for management of recurrent or persistent disease is allowed
• Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase III GOG protocol for the same patient population)
• GOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Saint Vincent Hospital and Health Services — Indianapolis, Indiana, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Maine Medical Center-Bramhall Campus — Portland, Maine, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Tulsa Cancer Institute — Tulsa, Oklahoma, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Zale Lipshy University Hospital — Dallas, Texas, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.