Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
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|ClinicalTrials.gov Identifier: NCT00031629|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma||Drug: Docetaxel Biological: Filgrastim Drug: Gemcitabine Hydrochloride Biological: Pegfilgrastim||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2007|
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.
Drug: Gemcitabine Hydrochloride
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031629
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Martee Hensley||Gynecologic Oncology Group|