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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01958580
Study type Interventional
Source Albert Einstein College of Medicine
Contact
Status Terminated
Phase N/A
Start date September 17, 2013
Completion date February 24, 2017

See also
  Status Clinical Trial Phase
Completed NCT00025220 - Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01220609 - Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
Recruiting NCT05633381 - Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working Phase 2/Phase 3
Terminated NCT01533207 - Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery Phase 3
Completed NCT00897442 - Collecting Tumor Samples From Patients With Gynecological Tumors N/A
Completed NCT00031629 - Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2
Active, not recruiting NCT03880019 - A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma Phase 2
Active, not recruiting NCT02428192 - Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma Phase 2