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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin
60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine
30 minute IV infusion on days 1 and 8 repeated every 21 days
Piedmont Cancer Institute
Atlanta, Georgia, United States
Piedmont Cancer Institute
Fayetteville, Georgia, United States
Piedmont Cancer Institute
Newnan, Georgia, United States
Maximum Tolerated Dose
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
Time frame: approx 63 days
Disease control rate (CR+PR+SD x18 weeks)
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.
Time frame: approx 63 days
Incidence of Treatment
Lab testing will be completed to evaluate standard of care labs for subject safety
Time frame: 63 days
Percent of patients who normalize their CA19-9
Lab testing will be completed to evaluate normalization of CA19-19
Time frame: 63 days
Overall survival (OS)
Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine survival status
Time frame: 12 weeks
Progression free
Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine status of disease progression
Time frame: approximately 12 weeks from last study treatment ]
Changes in patient's self-reported quality of life
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.
Time frame: 63 days
Changes in patient's self-reported pain levels
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.
Time frame: 63 days
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