NCT01281514

A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	everolimus	Given PO
DRUG	carboplatin	Given IV
DRUG	pegylated liposomal doxorubicin hydrochloride	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-12-14
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2011-01-24
• Last updated: 2019-07-11

Locations

1 site across 1 country: United States