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High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03797443
Recruitment Status : Withdrawn (Regulatory Review needed)
First Posted : January 9, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
Cancer Research UK
Stand Up To Cancer
Lustgarten Foundation
Destroy Pancreatic Cancer
Translational Genomics Research Institute
Information provided by (Responsible Party):
Piedmont Cancer Institute

Brief Summary:

The purpose of this study is to see if 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.

Vitamin C is a nutrient found in food and dietary supplements. It protects cells and also plays a key role in making collagen (which provides strength and structure to skin, bones, tissues and tendons). High-dose vitamin C may be given by intravenous (IV) infusion (through a vein into the bloodstream) or orally (taken by mouth). When taken by intravenous infusion, vitamin C can reach much higher levels in the blood than when the same amount is taken by mouth. Some 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.


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Ascorbic Acid Drug: nab paclitaxel Drug: Cisplatin Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Ascorbic Acid Paclitaxel Protein Bound Cisplatin Gemcitabine
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Had No Prior Therapy for Their Metastatic Pancreatic Cancer
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: AA NABPLAGEM
Ascorbic Acid Paclitaxel protein-bound cisplatin gemcitabine
Drug: Ascorbic Acid

Four escalating dose levels are planned in order to determine the MTD for Phase II

The dose level for Phase II patients will be determined following completion of the Phase 1b study based on response from 3-6 patients receiving the designated dose level of ascorbic acid.

Other Name: Vitamin C

Drug: nab paclitaxel
30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin

Drug: Cisplatin
60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine

Drug: Gemcitabine
30 minute IV infusion on days 1 and 8 repeated every 21 days




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: approx 63 days ]
    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

  2. Disease control rate (CR+PR+SD x18 weeks) [ Time Frame: approx 63 days ]
    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.


Secondary Outcome Measures :
  1. Incidence of Treatment [ Time Frame: 63 days ]
    Lab testing will be completed to evaluate standard of care labs for subject safety

  2. Percent of patients who normalize their CA19-9 [ Time Frame: 63 days ]
    Lab testing will be completed to evaluate normalization of CA19-19

  3. Overall survival (OS) [ Time Frame: 12 weeks ]
    Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine survival status

  4. Progression free [ Time Frame: approximately 12 weeks from last study treatment ] ]
    Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine status of disease progression

  5. Changes in patient's self-reported quality of life [ Time Frame: 63 days ]
    Changes in patient's self-reported quality of life will be determined by administering the MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) to assess the severity of multiple gastrointestinal cancer-related syymptoms and the impact of these symptoms of daily functiong.

  6. Changes in patient's self-reported pain levels [ Time Frame: 63 days ]
    Changes in patient's self-reported pain levels will be determined by administering the Brief Pain Inventory (BPI) to assess the severity of pain and the impact of pain on daily functions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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 21 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 through one month after the last dose of trial treatment.
  • Male participants must agree to use adequate contraception (as outlined in section 4.4.2) for the duration of the trial through one month after the last dose of trial treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

Exclusion Criteria:

  • 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 control of their diabetes being that 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.
  • For female participants: Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through one month after the last dose of trial treatment.
  • For male participants: Is expecting to impregnate a sexual partner within the projected duration of the trial, starting with the pre-screening or screening visit through one month after the last dose of trial treatment.
  • Patients with evidence of iron overload, defined as a transferrin saturation > 45 percent AND serum ferritin > 200 ng/mL (males) or >150 ng/mL (females).
  • Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797443


Locations
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United States, Georgia
Piedmont Cancer Institute
Atlanta, Georgia, United States, 30318
Piedmont Cancer Institute
Fayetteville, Georgia, United States, 30214
Piedmont Cancer Institute
Newnan, Georgia, United States, 30265
Sponsors and Collaborators
Piedmont Cancer Institute
Cancer Research UK
Stand Up To Cancer
Lustgarten Foundation
Destroy Pancreatic Cancer
Translational Genomics Research Institute

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Responsible Party: Piedmont Cancer Institute
ClinicalTrials.gov Identifier: NCT03797443     History of Changes
Other Study ID Numbers: PAN-VITC
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Piedmont Cancer Institute:
Metastatic Pancreatic Cancer
Cancer
Pancreatic
Vitamin C
Ascorbic Acid
Paclitaxel Protein Bound
Cisplatin
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vitamins
Ascorbic Acid
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents