A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with persistent or recurrent
platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer
treated with gemcitabine hydrochloride and intraperitoneal carboplatin.
- Evaluate the systemic and regional toxicity of this regimen in these patients.
Secondary
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal
carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Relative risk of progression-free survival
No
Noelle G. Cloven, MD
Study Chair
Methodist Estabrook Cancer Center
Unspecified
CDR0000496764
NCT00369954
April 2006
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