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
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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) Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have a cytological or histological diagnosis of adenocarcinoma arising in the pancreas. Diagnosis from metastatic sampling is acceptable.
- Disease must be measured radiologically.
- Failed initial therapy or ineligible for definitive curative therapy.
- If prior treatment included radiation therapy, recurrent disease must be outside of the targeted volume.
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
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Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 3,000/mm3
- absolute neutrophil count ≥ 1,500/mm3
- platelets ≥ 100,000/mm3
- total bilirubin < 2x institutional upper limit of normal
- AST(SGOT) < 3x institutional upper limit of normal OR < 5x institutional upper limit of normal for patients presenting with liver metastases
- ALT (SGPT) < 3x institutional upper limit of normal OR < 5x institutional upper limit of normal for patients presenting with liver metastases
- PT/INR within normal institutional limits, unless patient is on warfarin or other antithrombotic agents
- creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Not pregnant. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior chemotherapy to treat metastatic disease.
- Adjuvant therapy (including radiation therapy) within 4 calendar weeks.
- Unresolved toxicities from prior therapy for the malignancy.
- G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Second malignancy other than non-melanoma skin cancers within the past 5 years.
- Excess consumption of alcohol where an excess of alcohol is defined as more than four of any one of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL wine.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
- Pregnant or lactating women: The risks of chemotherapy to a fetus/infant are well documented.

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 | The University of Iowa | |
Study Chair: | Joseph J Cullen, MD | The University of Iowa |
Publications:
Responsible Party: | Joseph J. Cullen, Professor of Surgery, University of Iowa |
ClinicalTrials.gov Identifier: | NCT01515046 History of Changes |
Other Study ID Numbers: |
201204737 P30CA086862 ( U.S. NIH Grant/Contract ) |
First Posted: | January 23, 2012 Key Record Dates |
Results First Posted: | March 29, 2017 |
Last Update Posted: | June 8, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Joseph J. Cullen, University of Iowa:
Vitamins Complementary medicine Pancreatic cancer Ascorbate |
Ascorbic Acid Antioxidants Gemcitabine Pharmacologic actions |
Additional relevant MeSH terms:
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Vitamins Ascorbic Acid Gemcitabine Micronutrients Growth Substances |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Antioxidants Protective Agents |