A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

Official title:

A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049880
• Other study ID #: 200804753
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2010
• Last updated: April 19, 2017
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.

Description:

This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.

Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal G6PD status

• Histologically or cytologically diagnosed pancreatic adenocarcinoma.

• Disease extent documented by CT scan (radiologically measurable disease is not required)

• Ambulatory patient without evidence of spinal cord compression

• No prior chemotherapy for metastatic disease

• Failed curative therapy or patient ineligible for definitive curative therapy

• Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.

• If post-therapy, must have disease progression since that treatment

• If treated with prior radiation therapy, disease must be outside of the radiation fields

• No currently active second malignancies unless it is a non-melanoma skin cancer

• Women must be non-pregnant and non-lactating

• ECOG performance of 0, 1, or 2

• Granulocytes at least 1,500 / ul

• Platelets at least 100,000 / ul

• Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min

• Total bilirubin less than 2 times the upper limit of normal

• AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal

• PT INR less than 1.5 (unless the patient is on full dose warfarin)

• Patient must be at least 18 years of age

• Patient must be able to understand consent process, the research study, and be able to sign the consent document

Exclusion Criteria:

• A psychiatric disorder by history or examination that would prevent completion of the study

• ECOG performance of 3 or 4

• Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.

• Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs

• Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine with escalating ascorbic acid
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.

Locations

Country	Name	City	State
United States	The University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Joseph J. Cullen	Holden Comprehensive Cancer Center, University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (1)

Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancrea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)		weekly
Secondary	Plasma ascorbate level (targeted to 350 to 400 mg/dL)		Weekly
Secondary	Survival		Ongoing

External Links

•   Study results, free article.