Chemotherapy for Advanced or Recurrent Endometrial Cancer

Name of the Trial

Phase III Randomized Study of Doxorubicin, Cisplatin, Paclitaxel, and Filgrastim (G-CSF) Versus Carboplatin and Paclitaxel in Patients with Stage III or IV or Recurrent Endometrial Cancer (GOG-0209). See the protocol summary.

Principal Investigator

Dr. David Scott Miller Principal Investigator

Dr. David Scott Miller, Gynecologic Oncology Group.

Why This Trial Is Important

Endometrial cancer is cancer that arises from the lining of the uterus (the endometrium). It is the most common form of gynecologic cancer. Although endometrial cancer is curable in its early stages, advanced disease is often fatal.

Currently, there is no standard treatment for endometrial cancer that has spread beyond the uterus or recurred. Doctors treating patients with such cancers usually rely on one of two chemotherapy combinations: treatment with the drugs doxorubicin, cisplatin, and paclitaxel plus the biologic agent filgrastim (TAP) or with a combination of carboplatin and paclitaxel (TC).

In this trial, researchers will compare these two chemotherapy combinations in women with advanced or recurrent endometrial cancer to determine which combination will help patients survive longer. Additionally, the researchers will assess the patients' quality of life and examine the side effects of each combination.

"This is the most recent in a series of trials evaluating new drug treatments for endometrial cancer," said Dr. Miller. "In our previous studies, TAP emerged as the leading treatment choice. Many oncologists, however, use the TC combination, which is also used to treat ovarian cancer."

"This study is designed to set the standard of care for women with advanced endometrial cancer by comparing these two leading chemotherapy combinations," Dr. Miller said.

Who Can Join This Trial

Researchers seek to enroll 1528 patients aged 18 or over with confirmed stage III or stage IV or recurrent endometrial cancer who have not previously undergone chemotherapy. See the list of eligibility criteria.

Study Sites and Contact Information

Multiple study sites in the United States are recruiting patients for this trial. See the list of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The call is toll free and completely confidential.