Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer (PACMAN-II)
|ClinicalTrials.gov Identifier: NCT01515046|
Recruitment Status : Terminated (Standard of care changed to FOLFIRINOX; poor accrual.)
First Posted : January 23, 2012
Results First Posted : March 29, 2017
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Pancreatic Cancer||Drug: Gemcitabine with escalating ascorbic acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacological Ascorbate for the Control of Metastatic and Node-Positive Pancreatic Cancer (PACMAN): A Phase II Trial|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Gemcitabine with escalating IV ascorbate
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Drug: Gemcitabine with escalating ascorbic acid
Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
- Overall Survival [ Time Frame: up to 5 years ]Time to event outcome measure (death), measured in days from cycle 1 day 1.
- Progression Free Survival [ Time Frame: up to 5 years ]Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.
- Number of Drug-related Adverse Events Per Cycle [ Time Frame: every 28 days up to 5 years ]Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature
- F2-isoprostane Levels [ Time Frame: Once every 28 days for up to 5 years ]F2-isoprostane is a marker of systemic oxidative stress.
- Ascorbate Levels [ Time Frame: Once every 28 days up to 5 years ]Ascorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515046
|United States, Iowa|
|The Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Joseph J Cullen, MD||The University of Iowa|
|Study Chair:||Joseph J Cullen, MD||The University of Iowa|