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Recruitment Status : Withdrawn (Regulatory Review needed)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
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|
|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)|
|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|
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
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
- 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
- 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.
- Incidence of Treatment [ Time Frame: 63 days ]Lab testing will be completed to evaluate standard of care labs for subject safety
- Percent of patients who normalize their CA19-9 [ Time Frame: 63 days ]Lab testing will be completed to evaluate normalization of CA19-19
- 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
- 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
- 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.
- 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.
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
|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|