Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Conditions
Keywords
Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei, Pseudomyxoma Peritoneal, PMP, AMNs, Metformin
Brief summary
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).
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 pseudomyxoma peritonei (PMP) secondary to AMNs.
Interventions
DRUGMetformin
Given PO
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months | 6 months | Examine the feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 6, 12 and 18 months | 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. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATOROliver Eng, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed