NCT01958580

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma. SECONDARY OBJECTIVES: I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen. OUTLINE: CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Stage IA Uterine Sarcoma
• Stage IB Uterine Sarcoma
• Stage IC Uterine Sarcoma
• Stage IIA Uterine Sarcoma
• Stage IIB Uterine Sarcoma
• Stage IIIA Uterine Sarcoma
• Stage IIIB Uterine Sarcoma
• Stage IIIC Uterine Sarcoma
• Stage IVA Uterine Sarcoma
• Stage IVB Uterine Sarcoma
• Uterine Corpus Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	Gemcitabine Hydrochloride	Given IV
DRUG	Docetaxel	Given IV
RADIATION	Internal Radiation Therapy	Undergo brachytherapy
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
RADIATION	External Beam Radiation Therapy	Undergo EBRT
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-09-17
• Primary completion: 2017-02-24
• Completion: 2017-02-24
• First posted: 2013-10-09
• Last updated: 2023-08-16
• Results posted: 2023-08-16

Locations

1 site across 1 country: United States