Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
|Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma||Drug: Docetaxel Biological: Filgrastim Drug: Gemcitabine Hydrochloride Biological: Pegfilgrastim||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
- Frequency and duration of objective response [ Time Frame: Up to 5 years ]
- Frequency of severity of observed adverse effects assessed using CTC version 2.0 [ Time Frame: Up to 5 years ]The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
|Study Start Date:||January 2005|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Biological: Filgrastim
Other Names:Drug: Gemcitabine Hydrochloride
Other Names:Biological: Pegfilgrastim
I. Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031629
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Martee Hensley||Gynecologic Oncology Group|