Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Adverse events as assessed by NCI CTCAE v3.0 change from baseline [ Time Frame: every 21 days during treatment ] [ Designated as safety issue: Yes ]
- Response [ Time Frame: every 42 days until disease progression up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival change from baseline [ Time Frame: every 42 days until disease progression up to 5 years ] [ Designated as safety issue: No ]
- Recurrence-free survival [ Time Frame: every 42 days until disease progression up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Gemcitabine 800mg/m2 IV day 1 and 8 every 21 days
|Drug: gemcitabine hydrochloride|
- To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.
- To determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820898
Show 41 Study Locations
|Principal Investigator:||David L. Tait||Blumenthal Cancer Center at Carolinas Medical Center|