A Phase III Study of Gemcitabine, Docetaxel, and Doxorubicin versus Observation in Women with High-Grade Uterine Leiomyosarcoma

Protocol
12-177
Full Title
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma (GOG 277)(IRCI 001)
Phase
III
Purpose

Uterine leiomyosarcoma which has not spread beyond the uterus is usually treated with surgery. Patients are then monitored and given chemotherapy only if the cancer returns. In this Gynecologic Oncology Group study, researchers want to see if giving chemotherapy after surgery but before the tumor returns can decrease the chance of recurrence.

Patients will be randomly assigned to one of two groups. Half of the patients will receive the anticancer drugs gemcitabine and docetaxel followed by the drug doxorubicin after surgery. These are drugs commonly used to treat recurrent leiomyosarcoma, but using them right after surgery for leiomyosarcoma that has not spread beyond the uterus is considered investigational. The other half of the patients will not receive chemotherapy after surgery and will be monitored with CT scans.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have had leiomyosarcoma that was confined to the uterus and was surgically treated with hysterectomy. The surgery must have been completed within 3 months of entering the study.
  • Patients may not have cancer outside the uterus.
  • Patients may not have previously received gemcitabine, docetaxel, or doxorubicin, nor radiation therapy to the pelvis.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study or to inquire about eligibility, please contact Dr. Martee L. Hensley at 646-888-4222.

Disease(s)
Uterine Sarcoma: Leiomyosarcoma
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