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Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Primary Purpose

Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine and Erlotinib
Intravenous Vitamin C
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Metastatic pancreatic cancer
  • Glucose 6 phosphate dehydrogenase status normal
  • ECOG performance status 0-2
  • Normal creatinine and transaminase
  • Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

  • Concurrent chemotherapy or radiotherapy
  • Significant co-morbid disorders
  • Significant psychiatric symptoms
  • Prior treatment with gemcitabine
  • Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
  • Regular use of nonsteroidal anti-inflammatory agents
  • Smoking more than 1 pack per day
  • Excessive alcohol or drug use
  • Enrollment in other experimental therapy
  • Active infection
  • Patients experiencing ongoing response to recent treatments

Sites / Locations

  • Jefferson-Myrna Brind Center of Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous Vitamin C

Arm Description

Outcomes

Primary Outcome Measures

Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
August 4, 2009
Last Updated
June 18, 2018
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00954525
Brief Title
Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
Official Title
Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Vitamin C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine and Erlotinib
Intervention Description
Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Intravenous Vitamin C
Intervention Description
50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
Primary Outcome Measure Information:
Title
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic pancreatic cancer Glucose 6 phosphate dehydrogenase status normal ECOG performance status 0-2 Normal creatinine and transaminase Women of child-bearing potential confirm negative pregnancy test Exclusion Criteria: Concurrent chemotherapy or radiotherapy Significant co-morbid disorders Significant psychiatric symptoms Prior treatment with gemcitabine Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids) Regular use of nonsteroidal anti-inflammatory agents Smoking more than 1 pack per day Excessive alcohol or drug use Enrollment in other experimental therapy Active infection Patients experiencing ongoing response to recent treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Monti, MD, MBA
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson-Myrna Brind Center of Integrative Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22272248
Citation
Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
Results Reference
derived
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

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Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

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