Sarcoma Clinical Trial
Official title:
A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known whether ifosfamide alone is more effective
than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or
without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of
the uterus.
OBJECTIVES:
- Determine whether the addition of paclitaxel to ifosfamide improves length of survival,
progression free interval and response rate when compared to ifosfamide alone in
patients with advanced, refractory or recurrent carcinosarcoma (mixed mesodermal
tumors) of the uterus.
- Determine the toxicity of ifosfamide with paclitaxel in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to GOG performance
status (GOG 0-1 vs GOG 2-3) and randomized to one of two treatment arms.
- Arm I: Patients receive ifosfamide IV daily for 3 days every 21 days.
- Arm II: Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21
days. Filgrastim (G-CSF) is given subcutaneously beginning on day 4 until granulocyte
count is greater than 2,000/mm3. Paclitaxel therapy may precede or be given
concurrently with ifosfamide.
Treatment for both arms continues for a maximum of 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for an additional 3
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 patients (83 per arm) will be accrued for this study
within approximately 5.5 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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