Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HonorHealth Research Institute
• Collaborators: Barts Cancer Institute; Cancer Research UK; Cancer Research UK (CRUK); Cold Spring Harbor Laboratory; Imaging Endpoints; Lustgarten Foundation; Princeton University; Salk Institute for Biological Studies; Stand Up To Cancer; Translational Genomics Research Institute; University of Arizona
• Treatments: Albumin-Bound Paclitaxel; Ascorbic Acid; Cisplatin; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

• 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.