Clinical Trial: Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Brief Summary: 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. 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.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols.
II. 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.
Sponsor: Gynecologic Oncology Group
Current Primary Outcome:
- Frequency and duration of objective response assessed by RECIST [ Time Frame: Up to 5 years ]
- Frequency and severity of observed adverse effects assessed by CTCAE v3.0 [ Time Frame: Up to 5 years ]
- Overall survival [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: Up to 5 years ]
Original Primary Outcome:
- Adverse events as assessed by NCI CTCAE v3.0
- Response
- Progression-free survival
- Recurrence-free survival
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Gynecologic Oncology Group
Dates:
Date Received: January 9, 2009
Date Started: February 2009
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015
