Trial Outcomes & Findings for Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA (NCT NCT01550510)

Last Updated: 2025-05-06

Results Overview

Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

9 weeks +/- 2 weeks

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ascorbic Acid Ascorbic Acid (50-100g, 3x weekly) Ascorbic Acid: 3x a week for 9 weeks	Standard of Care (Irinotecan Alone) 350mg/m2 once a week every 3 weeks
Overall Study STARTED	4	0
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 9 weeks +/- 2 weeks

Population: The study was closed early due to lack of accrual. The data were not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 weeks +/- 2 weeks

Population: The study was closed early due to lack of accrual. The data were not collected or analyzed.

To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer

Outcome measures

Outcome data not reported

Adverse Events

Ascorbic Acid+Irinotecan

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard of Care (Irinotecan Alone)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ascorbic Acid+Irinotecan n=4 participants at risk Ascorbic Acid (50-100g, 3x weekly) Ascorbic Acid: 3x a week for 9 weeks	Standard of Care (Irinotecan Alone) 350mg/m2 once a week every 3 weeks
Blood and lymphatic system disorders Hypokalemia	25.0% 1/4 • Number of events 1 The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.	— 0/0 The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.
Blood and lymphatic system disorders Low Hemoglobin	25.0% 1/4 • Number of events 1 The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.	— 0/0 The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.

Additional Information

Dr. Daniel Monti

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215 955-2221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ascorbic Acid+Irinotecan n=4 Participants Ascorbic Acid (50-100g, 3x weekly) Ascorbic Acid: 3x a week for 9 weeks	Standard of Care (Irinotecan Alone) 350mg/m2 once a week every 3 weeks	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	—	4 participants n=5 Participants