Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

Purpose

This is a pilot, open-label clinical trial determining the feasibility of metformin therapy in subjects with pseudomyxoma peritoneal (PMP) secondary to appendiceal mucinous neoplasms (AMNs).

Conditions

  • Appendiceal Mucinous Neoplasm
  • Pseudomyxoma Peritonei

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

(complete details available in protocol): - Patients with clinical diagnosis of PMP secondary to presumed AMNs with recurrent/refractory disease s/p CRS/HIPEC, unresectable disease, or without planned CRS/HIPEC - Age ≥18 years - ECOG performance status ≤2

Exclusion Criteria

(complete details available in protocol): - Patients with a clinical diagnosis of PMP secondary to presumed AMNs with resectable disease who are planned to undergo CRS/HIPEC - Patients currently taking metformin for another medical indication - Patients with a prior adverse event to administration of metformin

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Metformin Treatment 		850mg PO daily
  • Drug: Metformin
    Given PO

Recruiting Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California 92868
Contact:
Oliver Eng, MD
877-827-8839
ucstudy@uci.edu

More Details

Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
1-877-827-8839
ucstudy@uci.edu

Detailed Description

This is a single-arm, prospective pilot/feasibility study. Treatment will continue for the duration of the study (18 months) or intolerance to treatment. The primary endpoint will be feasibility of metformin therapy in patients with PMP secondary to AMNs.