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Completed

NCT Number: NCT00954525

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

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.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jefferson-Myrna Brind Center of Integrative Medicine

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine and Erlotinib

Drug

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Intravenous Vitamin C

Dietary Supplement

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Progression-free survival

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2009
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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