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

NCT02336087 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: 14122NCI-2014-02612
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pancreatic Adenocarcinoma; Unresectable Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (3)

• Feasibility of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement

  Feasibility is defined at 1 or fewer patients experiencing a dose limiting toxicity within the first 6 patients.

  Up to 24 months

• Compliance of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (percent of patients who are fully compliant)

  The percent of patients who are fully compliant in the first week will be estimated with a 95% confidence interval. The compliance will be measured similarly for each course prior to study treatment discontinuation. The impact of less than full compliance (both during the lead-in period and during chemotherapy) on the biomarkers and outcome, and qualitatively study patient reasons and specific supplement patterns related to non-compliance will be explored.

  Up to 24 months

• Toxicity of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (National Cancer Institute Common Terminology for Adverse Events criteria version 4)

  Summarized using the National Cancer Institute Common Terminology for Adverse Events criteria version 4. Tables will summarize the highest grade per patient that is possibly related to treatment, and the number of patients requiring dose modifications will also be presented.

  Up to 24 months

Secondary Outcomes (3)

• Progression-free survival

  Up to 24 months

• Overall survival

  Up to 24 months

• Time to treatment failure

  Up to 24 months

Other Outcomes (2)

• Analysis of biological correlates (Peripheral blood will be evaluated)

  Up to 24 months

• Quality of life, assessed using the FACT-G questionnaire

  Up to 24 months

Study Arms (1)

Treatment (gemcitabine, Abraxane, metformin, DS)

EXPERIMENTAL

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.

Drug: Gemcitabine Hydrochloride; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Drug: Metformin Hydrochloride; Dietary Supplement: Therapeutic Dietary Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdC, dFdCyd

Treatment (gemcitabine, Abraxane, metformin, DS)

Metformin Hydrochloride DRUG

Given PO

Also known as: Glucophage, Metformin HCl

Treatment (gemcitabine, Abraxane, metformin, DS)

Paclitaxel Albumin-Stabilized Nanoparticle Formulation DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane

Treatment (gemcitabine, Abraxane, metformin, DS)

Therapeutic Dietary Intervention DIETARY_SUPPLEMENT

Given PO

Treatment (gemcitabine, Abraxane, metformin, DS)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (gemcitabine, Abraxane, metformin, DS)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (gemcitabine, Abraxane, metformin, DS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Rancho Cucamonga

Rancho Cucamonga, California, 91730, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

City of Hope West Covina

West Covina, California, 91790, United States

Location

MeSH Terms

Interventions

Gemcitabine; Taxes; Albumin-Bound Paclitaxel; Metformin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines

Study Officials

• Vincent Chung

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 12, 2015
• Study Start: January 14, 2016
• Primary Completion: October 4, 2020
• Study Completion (Estimated): December 9, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (4)