Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

This study has been completed.

Sponsor:

Information provided by:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT00954525

First received: August 4, 2009

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 4, 2009
Last Updated Date	January 17, 2012
Start Date ^ICMJE	July 2009
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 Arm (s)	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. 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
Enrollment ^ICMJE	14
Completion Date	December 2011
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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00954525
Other Study ID Numbers ^ICMJE	IND77486
Has Data Monitoring Committee	Yes
Responsible Party	Daniel A. Monti, MD, Thomas Jefferson University
Study Sponsor ^ICMJE	Thomas Jefferson University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Thomas Jefferson University
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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