Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Pancreatic Neoplasms, Pancreatic Cancer

In brief

This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening survival time for patients with advanced pancreatic cancer.

Key facts

Study ID

NCT01515046

Run by

Joseph J. Cullen

People needed

1

Starts

2012-09-01

Expected to finish

2016-12-01

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• 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.

Where it is running

• The Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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