Summary

for people ages 18 years and up (full criteria)
study started
estimated completion:
Hitendra Patel

Description

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.

Official Title

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

Keywords

Metastatic Pancreatic Cancer cancer pancreatic Vitamin C Ascorbic Acid Nanoparticle Paclitaxel Protein Bound cisplatin gemcitabine Pancreatic Neoplasms Vitamins Paclitaxel Albumin-Bound Paclitaxel Paclitaxel protein-bound AA NABPLAGEM

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1 criteria).
  • Adequate organ function

You CAN'T join if...

  • 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
  • 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
  • Any person with a G6PD deficiency
  • History of renal oxalate stones
  • Patient is taking acetaminophen at any dose, or any medication that contains acetaminophen within 72 hours of first dose of ascorbic acid.
  • 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.
  • Is pregnant or breastfeeding
  • Current, serious, clinically significant cardiac arrhythmias or receiving a digitalis derivative.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hitendra Patel
ID
NCT03697239
Phase
Phase 1/2
Lead Scientist
Hitendra Patel
Study Type
Interventional
Last Updated
October 3, 2018