Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

ConditionsAppendiceal Mucinous Neoplasm Pseudomyxoma Peritonei

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Irvine

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Metformin
Drug
Given PO

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Metformin TreatmentExperimental treatment 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov

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