Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer (PACMAN-II)
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|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.
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): NCT01515046
|United States, Iowa|
|The Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Joseph J Cullen, MD||University of Iowa|
|Study Chair:||Joseph J Cullen, MD||University of Iowa|