Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
|ClinicalTrials.gov Identifier: NCT00114218|
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : December 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma||Drug: Gemcitabine Hydrochloride Drug: Docetaxel||Phase 2|
I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||July 2010|
Experimental: Treatment (gemcitabine hydrochloride, docetaxel)
Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Drug: Gemcitabine Hydrochloride
Other Names:Drug: Docetaxel
Other Name: TXT
- Frequency and duration of objective response according to RECIST [ Time Frame: Up to 5 years ]
- Frequency and severity of observed adverse effects [ Time Frame: Up to 5 years after completion of study treatment ]Tabulated from submitted case report forms.
- Survival time [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]
- Duration of progression-free interval [ Time Frame: From study entry until disease progression, death, or date of last contact, assessed up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114218
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Brigitte Miller||Gynecologic Oncology Group|