Combination Chemotherapy + Metformin + Dietary Supplement for Pancreatic Cancer

Palo Alto (17 mi)

Overseen byVincent Chung

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with pancreatic cancer that can't be surgically removed. They should have normal bilirubin and creatinine levels, not be severely ill from other causes, able to swallow pills without vomiting issues, and not pregnant or nursing. Prior chemotherapy is mostly excluded except under certain conditions.

Treatment Details

The trial tests the combination of chemotherapy drugs gemcitabine hydrochloride and nab-paclitaxel with diabetes drug metformin hydrochloride and a dietary supplement mix aimed at targeting various aspects of cancer cell growth in patients with inoperable pancreatic cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (gemcitabine, Abraxane, metformin, DS)Experimental Treatment6 Interventions

Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Patients also receive metformin hydrochloride PO BID starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Gemcitabine Hydrochloride is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: