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

NCT01550510 | Terminated Phase 1 Results DMC

• 2 other identifiers: 11D.459JT 1548
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

  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.

  9 weeks +/- 2 weeks

Secondary Outcomes (1)

• Number of Participants That Are Alive After 11 Weeks.

  9 weeks +/- 2 weeks

Study Arms (2)

Ascorbic Acid + Irinotecan

EXPERIMENTAL

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

Drug: Ascorbic Acid; Drug: Irinotecan

Standard of Care (irinotecan alone)

ACTIVE COMPARATOR

350mg/m2 irinotecan once a week every 3 weeks

Drug: Irinotecan

Interventions

Ascorbic Acid DRUG

3x a week for 9 weeks

Also known as: Ascorbate, Vitamin C

Ascorbic Acid + Irinotecan

Irinotecan DRUG

350mg/m2 once a week every 3 weeks

Also known as: Camptothecin-11, CPT-11

Ascorbic Acid + Irinotecan; Standard of Care (irinotecan alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Metastatic colorectal carcinoma (stage IV disease).
• Patients must have progressed on one or more prior chemotherapy treatment regimens including at least one trial of a 5-FU/oxaliplatin based therapy (FOLFOX) in combination with bevacizumab. Patients must not have had standard chemotherapy within at least 2 weeks of beginning ascorbic acid treatment provided that they have recovered from any toxicities that they experienced.
• G6PD status \> lower limit of normal
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study.
• Willing and able to provide informed consent and participate in the study procedures.

You may not qualify if:

• Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate.
• Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).
• Patients who currently abuse alcohol or drugs.
• Patients with known glomerular filtration rate of \<60ml/min or with nephrotic range proteinuria.
• Pregnant or lactating women
• Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days.
• Contraindication for CT or PET/CT as per the PI.
• Patients who are on strong inducers of CYP3A4 which include but are not limited to: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Dexamethasone, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's wort.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Interventions

Ascorbic Acid; Irinotecan

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Daniel Monti
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

daniel.monti@jefferson.edu

215 955-2221

Study Officials

• Daniel A Monti, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 12, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 6, 2025
• Results First Posted: August 24, 2018

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)