Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

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

Tracking Information

• First Submitted Date: August 4, 2009
• First Posted Date: August 7, 2009
• Last Update Posted Date: June 20, 2018
• Study Start Date: July 2009
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: August 5, 2009): Progression-free survival [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Pancreatic Cancer

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 17, 2012): 14
• Original Estimated Enrollment (submitted: August 5, 2009): 9
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00954525
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
• Original Responsible Party: Daniel A. Monti, MD, Thomas Jefferson University
• Current Study Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Original Study Sponsor: Thomas Jefferson University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel Monti, MD, MBA; Sidney Kimmel Cancer Center at Thomas Jefferson University

• PRS Account: Thomas Jefferson University
• Verification Date: June 2018