Conditions: Stage IV Colorectal Cancer
Keywords: Stage IV Colorectal cancer Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Ascorbic Acid Vitamins Irinotecan Integrative Medicine Complementary Medicine Alternative Medicine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Detailed description:
Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Arms:
arm 1: Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks arm 2: 350mg/m2 irinotecan once a week every 3 weeks

Interventions: intervention 1: Ascorbic Acid intervention 2: Irinotecan
Intervention descriptions: intervention 1: 3x a week for 9 weeks intervention 2: 350mg/m2 once a week every 3 weeks

Protocol document: