Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Conditions

• Stage IV Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ascorbic Acid — DRUG
  3x a week for 9 weeks
• Irinotecan — DRUG
  350mg/m2 once a week every 3 weeks

Study Details

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.

Key Dates

Start date

Dec 31, 2011

Status verified

May 2025

Primary completion

Feb 28, 2015

Completion

Feb 28, 2015

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ascorbic Acid + Irinotecan
  Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks
• Active Comparator: Standard of Care (irinotecan alone)
  350mg/m2 irinotecan once a week every 3 weeks

Primary Outcome Measure

Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. [ Time Frame: 9 weeks +/- 2 weeks ]

Locations (1)

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