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:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:January 2016
End Date:August 2019

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

This pilot phase I trial studies the side effects of 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. 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.

PRIMARY OBJECTIVES:

I. To assess the compliance, toxicity and feasibility of administering gemcitabine
(gemcitabine hydrochloride), Abraxane (paclitaxel albumin-stabilized nanoparticle
formulation), metformin (metformin hydrochloride), and the dietary supplement (DS).

SECONDARY OBJECTIVES:

I. To assess the response rate associated with this combination therapy in pancreatic cancer
patients.

II. To assess the progression-free survival and overall survival of all patients who start
protocol therapy, and describe the outcomes based on measures of compliance during the
lead-in week, and compliance with supplement during chemotherapy.

III. To collect and analyze peripheral blood and pre-treatment biopsy samples for an
exploratory analysis of biological correlatives.

IV. To assess quality of life utilizing the Functional Assessment of Cancer Therapy-General
(FACT-G) questionnaire.

OUTLINE:

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

After completion of study treatment, patients are followed up every 6 months.

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
We found this trial at
4
sites
Rancho Cucamonga, California 91730
Phone: 626-256-4673
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Rancho Cucamonga, CA
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Duarte, California 91010
Principal Investigator: Vincent Chung
Phone: 626-471-9200
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Duarte, CA
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South Pasadena, California 91030
Phone: 626-256-4673
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South Pasadena, CA
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West Covina, California 91790
Phone: 626-256-4673
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West Covina, CA
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