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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01550510
First received: February 23, 2012
Last updated: February 4, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Stage IV Colorectal Cancer
Drug: Vitamin C
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Safety [ Time Frame: 9 weeks +/- 2 weeks ] [ Designated as safety issue: Yes ]
    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

  • Efficacy [ Time Frame: 9 weeks +/- 2 weeks ] [ Designated as safety issue: No ]
    To utilize CT or PET/CT scans to assess overall tumor response rate (complete and partial response) and evaluate disease progression in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.


Secondary Outcome Measures:
  • Survival [ Time Frame: 9 weeks +/- 2 weeks ] [ Designated as safety issue: No ]
    To evaluate duration of tumor response, progression-free survival and quality of life related to treatment of patients with advanced or recurrent colorectal cancer


Estimated Enrollment: 48
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascorbic Acid
Ascorbic Acid (50-100g, 3x weekly)
Drug: Vitamin C
3x a week for 9 weeks
Other Names:
  • Ascorbic Acid
  • Ascorbate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 100,000/mm3;
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550510

Contacts
Contact: Michael J Matthews 215-503-7329 michael.matthews@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael J Matthews    215-503-7329    michael.matthews@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Daniel A Monti, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01550510     History of Changes
Other Study ID Numbers: 11D.459
Study First Received: February 23, 2012
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Rectal Diseases
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
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

Additional relevant MeSH terms:
Rectal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Ascorbic Acid
Vitamins
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Protective Agents
Micronutrients
Growth Substances
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014