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ACTIVE NOT RECRUITING
NCT02336087
PHASE1

Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This pilot phase I trial studies the side effects of gemcitabine hydrochloride, nab-paclitaxel, metformin hydrochloride, and a standardized dietary supplement in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer cells. Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium broccoli sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc amino chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in the cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and metformin hydrochloride with a dietary supplement may work better in treating patients with pancreatic cancer that cannot be removed by surgery.

Official title: A Pilot Study of Gemcitabine, Abraxane, Metformin and a Standardized Dietary Supplement (DS) in Patients With Unresectable Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2016-01-14

Completion Date

2026-12-09

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Given IV

DRUG

Metformin Hydrochloride

Given PO

DIETARY_SUPPLEMENT

Therapeutic Dietary Intervention

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Locations (4)

City of Hope Medical Center

Duarte, California, United States

City of Hope Rancho Cucamonga

Rancho Cucamonga, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope West Covina

West Covina, California, United States