High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
NCT ID: NCT03797443
Last Updated: 2019-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2019-01-01
2022-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AA NABPLAGEM
Ascorbic Acid Paclitaxel protein-bound cisplatin gemcitabine
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.
nab paclitaxel
30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin
Cisplatin
60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine
Gemcitabine
30 minute IV infusion on days 1 and 8 repeated every 21 days
Interventions
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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.
nab paclitaxel
30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin
Cisplatin
60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine
Gemcitabine
30 minute IV infusion on days 1 and 8 repeated every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Stand Up To Cancer
OTHER
Lustgarten Foundation
OTHER
Destroy Pancreatic Cancer
OTHER
Translational Genomics Research Institute
OTHER
Piedmont Cancer Institute
OTHER
Responsible Party
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Locations
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Piedmont Cancer Institute
Atlanta, Georgia, United States
Piedmont Cancer Institute
Fayetteville, Georgia, United States
Piedmont Cancer Institute
Newnan, Georgia, United States
Countries
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Other Identifiers
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PAN-VITC
Identifier Type: -
Identifier Source: org_study_id