Clinical Trial: Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. 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.

Detailed Summary:

OBJECTIVES:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: June 13, 2005
Date Started: March 2005
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014