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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Metformin Treatment |
850mg PO daily |
|
Recruiting Locations
Orange, California 92868
More Details
- Status
- Recruiting
- Sponsor
- University of California, Irvine
Study Contact
Chao Family Comprehensive Cancer Center University of California, Irvine1-877-827-8839
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.