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Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00954525
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE August 4, 2009
First Posted Date  ICMJE August 7, 2009
Last Update Posted Date June 20, 2018
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00954525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
Progression-free survival [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
Official Title  ICMJE Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: Gemcitabine and Erlotinib
    Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
  • Dietary Supplement: Intravenous Vitamin C
    50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
Study Arms  ICMJE Experimental: Intravenous Vitamin C
Interventions:
  • Drug: Gemcitabine and Erlotinib
  • Dietary Supplement: Intravenous Vitamin C
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2009)
9
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954525
Other Study ID Numbers  ICMJE 09D.99
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Monti, MD, MBA Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP