Overview

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

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Metformin
Paclitaxel
Criteria
Inclusion Criteria:

- Patients must have a histologic diagnosis of pancreatic adenocarcinoma

- Patient must have unresectable disease

- Patients must not have received prior chemotherapy except for the following
circumstances; gemcitabine and capecitabine chemotherapy given in the adjuvant setting
is allowed if the recurrence is greater than 6 months from the completion of
chemotherapy; radiation sensitizing doses of 5-fluororuracil or capecitabine are
allowed as part of adjuvant treatment and recurrence must be documented greater than 6
months from the completion of adjuvant therapy

- Computed tomography (CT) or magnetic resonance imaging (MRI) scan must be obtained
within 4 weeks prior to study entry

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Absolute neutrophil count > 1,500/mcl

- Platelet count > 100,000/mcl

- Creatinine < 1.4 mg/dl and/or a measured creatinine clearance > 60 cc/min

- Bilirubin < 1.4 mg/dl

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 3.0
times the upper limit of normal

- Patients currently being treated for severe infections or who are recovering from
major surgery or other intercurrent illnesses are ineligible until recovery is deemed
complete by the investigator

- Patients must not be pregnant or nursing; women and men of reproductive potential must
have agreed to use an effective contraceptive method

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines

- Patients must be able to swallow pills and must not have malabsorption problems or
ongoing nausea and vomiting that would affect oral treatment

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or any
other cancer from which the patient has been disease free for five years

- Patients currently taking metformin will be eligible

- Patients allergic to eggs are not eligible

- Patients taking additional dietary/herbal supplements (excluding Senekot) outside of
this protocol and refusing to stop are not eligible

- Patients requiring warfarin are not eligible