Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

Phase 2RecruitingNCT07693452

University of California, Irvine15 enrolled

Overview

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

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 pseudomyxoma peritonei (PMP) secondary to AMNs.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Appendiceal Mucinous Neoplasm Pseudomyxoma Peritonei

Interventions

MetforminDRUG

Given PO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria (complete details available in protocol): * Patients with clinical diagnosis of pseudomyxoma peritonei (PMP) secondary to presumed appendiceal mucinous neoplasms (AMNs) with recurrent/refractory disease s/p cytoreductive surgery(CRS)/hyperthermic intraperitoneal chemotherapy (HIPEC), unresectable disease, or without planned CRS/HIPEC * Age ≥18 years * ECOG performance status ≤2 Key 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

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

RECRUITING

Outcomes

Primary Outcomes

Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months

Examine the feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs)

Time frame: 6 months

Secondary Outcomes

Progression Free Survival (PFS)

Examine efficacy of metformin therapy in patients with PMP secondary to AMNs as assessed by progression free survival (PFS). Progression free survival will be defined by relative best tumor size change from baseline ranging from -100% to 100%, with radiographic findings assessed via modified peritoneal RECIST criteria at 6/12/18 months.

Time frame: 6, 12 and 18 months

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839 ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Data from ClinicalTrials.gov

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