Fallopian Tube Cancer Clinical Trial
Official title:
Phase I Study of Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Everolimus in Patients With Platinum-Sensitive Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer in First Relapse
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal
doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Everolimus may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and
PLD together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when
given together with carboplatin and PLD in treating patients with relapsed ovarian
epithelial, fallopian tube, or peritoneal cavity cancer
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of RAD001 (everolimus) in combination with
carboplatin and PLD.
SECONDARY OBJECTIVES:
I. Determine safety/tolerability of the three drug combination of carboplatin, PLD and RAD001
(everolimus).
II. Determine preliminary analysis of anti-tumor activity of this regimen in patients with
recurrent ovarian, fallopian tube or primary peritoneal cancers.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive carboplatin intravenously (IV) and PLD IV on day 1 and everolimus orally
(PO) once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 1 year.
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