Status:
TERMINATED
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
Lead Sponsor:
Joseph J. Cullen
Collaborating Sponsors:
Susan L Bader Foundation of Hope
Holden Comprehensive Cancer Center
Conditions:
Pancreatic Neoplasms
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 tol...
Detailed Description
Adenocarcinoma of the pancreas is the fourth leading cause of cancer death in the United States and is increasing in incidence; the prognosis remains dismal. We propose to investigate an entirely new ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01515046
Start Date
September 1 2012
End Date
December 1 2016
Last Update
June 8 2017
Active Locations (1)
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1
The Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242