Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Frequency and duration of objective response [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Survival time [ Designated as safety issue: No ]
- Duration of progression-free interval [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.
- 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.