Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Disease Progression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

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Antimitotic Agents

Antimetabolites

Paclitaxel Protein bound, Cisplatin, and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced.

Paclitaxel Protein bound and Gemcitabine until stable or progressive disease, at which point Paricalcitol will be introduced.

paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced

Paclitaxel protein bound

Paricalcitol

PINBALL Coordinator

David Propper

This is a phase II pilot trial of Paclitaxel Protein Bound and Gemcitabine based chemotherapy and the addition of Paricalcitol upon attainment of stable or progressive disease in eligible patients with untreated metastatic pancreatic ductal adenocarcinoma.

Pancreatic cancer is the fourth-highest cancer killer worldwide with an overall 5 year survival of about 8%. The only potentially curative procedure, surgical excision, is feasible in a minority of patients, but even in these patients the majority (\~80%) die within 5 years. This study aims to see if adding paricalcitol (a vitamin D analogue) to chemotherapy can slow down tumour growth in patients with previously untreated metastatic pancreatic cancer.

Studies have shown vitamin D can change the pancreatic tumour microenvironment from an immunologically suppressive (tumour growth promoting) to an immunologically hostile one, slowing down tumour growth in this way.

Patients with pancreatic cancer that has spread to other organs and who have adequate hepatic and renal function are eligible. Participants will receive chemotherapy (paclitaxel and gemcitabine, with or without cisplatin). On development of stable disease or disease progression, paricalcitol will be added to the chemotherapy regimen and participants will continue on this treatment until their cancer stops responding to treatment. After that participants will be followed up 3 monthly for the collection of disease status and survival data.

Participants will be asked to donate tumour and blood samples to allow the research team to look at the effects on the tumour biology.

Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

A Phase II Pilot Trial Of Paclitaxel Protein Bound and Gemcitabine Based Chemotherapy and the Addition Of Paricalcitol Upon Attainment of Stable or Progressive Disease in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

To determine the clinical benefit of adding paricalcitol to the regimens of either paclitaxel protein bound plus gemcitabine or paclitaxel protein bound plus cisplatin plus gemcitabine for patients with stable or progressive metastatic PDA.

Barts & The London NHS Trust

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Micronutrients

Vitamins

Ascorbic Acid

Trace Elements

Antioxidants

Protective Agents

Vitamin C

Ascorbic Acid Paclitaxel protein-bound cisplatin gemcitabine

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

nab paclitaxel

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

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.

Ascorbic Acid Paclitaxel Protein Bound Cisplatin Gemcitabine

High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer

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

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

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.

Lab testing will be completed to evaluate standard of care labs for subject safety

Lab testing will be completed to evaluate normalization of CA19-19

Telephone followup will be conducted every 12 weeks from the last dose of treatment to determine survival status

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 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 will be determined by administering the Brief Pain Inventory (BPI) to assess the severity of pain and the impact of pain on daily functions.

Cancer Research UK

Stand Up To Cancer

Lustgarten Foundation

Destroy Pancreatic Cancer

Translational Genomics Research Institute

Piedmont Cancer Institute

Anti-Infective Agents

Antirheumatic Agents

Gastrointestinal Agents

Hydroxychloroquine

Pancrelipase

Pancreatin

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine

Erkut Borazanci, MD

To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.

Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer

A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin+ Hydroxychlororoquine as Preoperative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas

Evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.

Assess the resectability rate following neoadjuvant chemotherapy

Assess the 2 year survival from date of study entry

Assess the pathologic complete response rate and radiologic response rate

Assess the Grade 3 or Grade 4 related adverse events as assessed by CTCAE Version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma	NCT04054362	Pancreatic Canc...	Paclitaxel prot... Cisplatin Gemcitabine Paricalcitol	18 Years -	Barts & The London NHS Trust
High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer	NCT03797443	Metastatic Panc...	Ascorbic Acid nab paclitaxel Cisplatin Gemcitabine	18 Years -	Piedmont Cancer Institute
High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer	NCT03797443	Metastatic Panc...	Ascorbic Acid nab paclitaxel Cisplatin Gemcitabine	18 Years -	Piedmont Cancer Institute
Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer	NCT04669197	Untreated Resec... Borderline Rese... Locally Advance...	Paclitaxel prot... Gemcitabine Cisplatin Hydroxychloroqu...	18 Years -	HonorHealth Research Institute

Spots Global Cancer Trial Database for paclitaxel protein bound