Page 12 - Delaware Medical Journal August 2015
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
GOG-0277: 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
The objectives of the trial are: Primary Objective:
To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin com- pared to patients assigned to observation.
Secondary Objectives:
• To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.
• To explore the impact of potential predictors of recurrence or death such as patient age, and institution reported tumor size, cervix involvement (yes or no), and mitotic rate.
Eligibility:
• uterine serosa involvement are not eligible. Patients should have had, at least, a complete hysterectomy (including removal of the cervix). Bilateral salpingo-oophorectomy is not required. Pathology must indicate High-Grade.
• Patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study.
• May not have had prior therapy with docetaxel or gemcitabine or doxorubicin.
•
• Adequate organ function.
•
• 18 years of age 1.
Treatment:
Patients randomly assigned to Regimen I will be treated as follows:
hours prior to docetaxel)
Patients randomly assigned to Regimen I will be treated as follows:
Observation only
• •
document patient-reported toxicities or adverse events
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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