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Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Stage IV Colorectal Cancer

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Trial Information

Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Inclusion Criteria:

- 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.

- Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper
limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine
clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal;
bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥

- 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.

Exclusion Criteria:

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

9 weeks +/- 2 weeks

Safety Issue:


Principal Investigator

Daniel A Monti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Stage IV Colorectal Cancer
  • 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
  • Colorectal Neoplasms



Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541