Conditions: Stage IV Pancreatic Cancer
Keywords: Pancreatic Neoplasms Pancreatic Cancer cells Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Ascorbic Acid Gemcitabine Vitamins Vitamin C Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Erlotinib Integrative Medicine Alternative Medicine Complementary Medicine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data

Detailed description:
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.

Arms:
arm 1: Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Interventions: intervention 1: Ascorbic Acid
Intervention descriptions: intervention 1: 3x per week

Protocol document: