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

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph J. Cullen
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); Susan L Bader Foundation of Hope
• Treatments: Ascorbic Acid; Gemcitabine; Vitamins

Criteria

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).

• 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.