Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, 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) and giving them in
different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine
together with carboplatin works in treating patients with persistent or recurrent ovarian
epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to
previous cisplatin or carboplatin.
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.
;
Primary Purpose: Treatment
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