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
17
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
Longer than P75 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
September 6, 2023
CompletedResults Posted
Study results publicly available
July 23, 2026
CompletedJuly 23, 2026
August 1, 2025
3.8 years
January 9, 2018
May 14, 2025
June 25, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)]
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, the total dose received of ascorbic acid (g/m\^2) by participants was measured.
From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)]
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, the duration of ascorbic acid dose in days is reported.
From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)]
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, the duration of ascorbic acid dose in weeks is reported.
From enrollment through end of treatment, up to 40 weeks
Disease Control Rate (CR+PR+SD at 18 Weeks)
Preliminary efficacy as measured by disease control rate (DCR), defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) at 18 weeks according to RECIST v1.1. CR = disappearance of all target lesions; PR = at least 30% decrease in sum of the longest diameters for target lesions, SD = insufficient change to qualify for PR or progressive disease \[defined as at least 20% increase in sum of the longest diameters for target lesions\].
18 weeks
Best Overall Response
Best overall response according to RECIST v1.1. Complete response (CR) = disappearance of all target lesions; Partial response (PD) = at least 30% decrease in sum of the longest diameters for target lesions; Stable disease (SD) = insufficient change to qualify for PR or PD; Progressive disease (PD) = at least 20% increase in sum of the longest diameters for target lesions.
From enrollment through end of treatment, up to 36 weeks
Secondary Outcomes (6)
Incidence of Toxicities
From enrollment through 30 days after the end of treatment, up to 40 weeks
Normalization of Tumor Markers by AA Treatment Group
From enrollment through study completion, up to 40 weeks
Overall Survival
Approximately 12 weeks from last study treatment, assessed up to 3 years
Progression-free Survival
Approximately 12 weeks from last study treatment, assessed up to 3 years
Quality of Life: MD Anderson's Symptom Inventory-GI (MDASI-GI)
From Cycle 1 to end of treatment, up to 40 weeks
- +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 (4)
High Dose Ascorbic Acid 25 g/m^2
EXPERIMENTAL25 grams/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
High Dose Ascorbic Acid 37.5 g/m^2
EXPERIMENTAL37.5 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
High Dose Ascorbic Acid 56.25 g/m^2
EXPERIMENTAL56.25 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
High Dose Ascorbic Acid 75 g/m^2
EXPERIMENTAL75 g/m\^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 \& 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Interventions
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
30 minute IV infusions on days 1 and 8 repeated every 21 days
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
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)
Results Point of Contact
- Title
- Gayle Jameson, MSN, ACNP-BC, AOCN
- Organization
- HonorHealth
Study Officials
- PRINCIPAL INVESTIGATOR
Gayle S Jameson, RN, MSN, ACNP-BC, AOCN
HonorHealth Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- 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
September 6, 2023
Last Updated
July 23, 2026
Results First Posted
July 23, 2026
Record last verified: 2025-08
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.