Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
AA NABPLAGEM
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of this study is to see if a treatment regimen with a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pancreatic-cancer
Started Dec 2017
Typical duration for phase_1 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedApril 18, 2023
April 1, 2023
3.8 years
January 9, 2018
April 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Phase IB: Recommended Phase II dose (to give ≥ 20 mM) of ascorbic acid for Phase II
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer
approximately 63 days
Phase II: Disease control rate (CR+PR+SD x18 weeks)
To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 18 weeks) of the combination of high dose ascorbic acid (AA) at MTD with triple therapy of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer.
approximately 63 days
Secondary Outcomes (6)
Incidence of toxicities
approximately 63 days
Percent of patients who normalize their CA19-9
approximately 63 days
overall survival
approximately 12 weeks from last study treatment
Progression free
approximately 12 weeks from last study treatment
Changes in patient's self-reported quality of life
approximately 63 days
- +1 more secondary outcomes
Other Outcomes (5)
Tumor texture on radiologic scans
approximately 63 days
Correlation between peak plasma concentration of ascorbic acid and response to treatment
approximately 63 days
Potential tumor biomarkers
approximately 63 days
- +2 more other outcomes
Study Arms (1)
Ascorbic Acid
EXPERIMENTALSome human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials
Interventions
combination therapy
combination therapy
combination therapy
combination therapy
Eligibility Criteria
You may qualify if:
- Patients must meet the following criteria to be included in the trial:
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1 criteria).
- Have a performance status of 0 or 1 on the ECOG performance scale.
- Demonstrate adequate organ function as defined below in table 4. All screening labs should be performed within 14 days of treatment initiation.
- Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication.
- Female participants of childbearing potential must be willing to use adequate method of contraception (as outlined in section 4.4.2) for the duration of the trial.
- Male participants must agree to use adequate contraception (as outlined in section 4.4.2) for the duration of the trial.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
You may not qualify if:
- Patients must not meet any of the following criteria in order to be eligible for the trial:
- Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
- Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
- Patients who need constant use of finger stick blood glucose monitoring for tight contro l of their diabetes being the ascorbic acid causes false low readings of glucose via that technology (Vasudevan and Hirsch 2014) 39
- Any person with a G6PD deficiency
- History of renal oxalate stones (if type of stone is unknown, need to assess urine oxalates level if \>60mg/dL, then patient is not eligible for the study)
- Patient is taking acetaminophen at any dose, or any medication that contains acetaminophen within 72 hours of first dose of ascorbic acid.
- Hypersensitivity to any of the agents proposed for treatment.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through one week from the last dose of trial treatment.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HonorHealth Research Institutelead
- Stand Up To Cancercollaborator
- Cancer Research UKcollaborator
- Lustgarten Foundationcollaborator
- Translational Genomics Research Institutecollaborator
- Princeton Universitycollaborator
- Salk Institute for Biological Studiescollaborator
- Cold Spring Harbor Laboratorycollaborator
- Barts Cancer Institutecollaborator
- University of Arizonacollaborator
- Imaging Endpointscollaborator
Study Sites (1)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Related Publications (1)
Jameson GS, LeGrand SD, Gordon MS, Roe DJ, Wertheim BC, Olszewski K, Rabinowitz J, Evans R, Downes M, Truitt M, Korn R, Han H, Miller RM, Barrett MT, Propper D, Von Hoff DD, Borazanci E. Phase IB trial of high dose ascorbic acid + nab-paclitaxel + cisplatin + gemcitabine in patients with untreated metastatic pancreatic cancer. Redox Biol. 2025 Dec;88:103895. doi: 10.1016/j.redox.2025.103895. Epub 2025 Oct 25.
PMID: 41197185DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gayle S Jameson, RN, MSN, ACNP-BC, AOCN
HonorHealth Research Institute
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 9, 2018
First Posted
January 25, 2018
Study Start
December 15, 2017
Primary Completion
September 14, 2021
Study Completion
January 10, 2022
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- to be determined
- Access Criteria
- The Investigator and any other study personnel involved in this study shall not disclose, or use for any purposes (other than for the performance of this study), any data, records, or other information (hereinafter collectively "information") disclosed to the Investigator or other study personnel. Such information shall remain the confidential and proprietary property of HonorHealth, and shall be disclosed only to the Investigator or other designated study personnel. The obligation of non-disclosure shall not apply to the following: * relevant disclosure to potential study participants for the purpose of obtaining informed consent; * information after such time that it is or becomes publicly available through no fault of the Investigator or other study personnel; and, * information after such time that it is disclosed to the Investigator by a third party entitled to disclose such information.
If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees for the purposes of regulatory submissions, study publications, and drug approval. SU2C will be notified of any outputs of the research such as guidelines, publications, presentation, changes in service delivery etc. prior to external submission or presentation. In any oral or written report or poster presentation of Results or otherwise relating to the Research, the support of CRUK, SU2C and the Lustgarten foundation will be acknowledged, displaying the relevant logs where possible. Any publications resulting from research funded in whole or in part by the Grant must be cited as required per signed confidentiality agreements.