Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Colorectal Cancer

In brief

Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin during their treatment for cancer because of the purported health benefits. This research study is designed to learn more about the safety, pharmacokinetics and effectiveness of irinotecan when given in combination with curcumin in patients with metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better understand the interaction between curcumin and irinotecan by measuring levels of irinotecan in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information collected from this study could result in improved dosing guidelines and lead to more effective treatment of your cancer with less toxicity.

Key facts

Study ID: NCT01859858
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 23
Starts: 2013-06-01
Expected to finish: 2016-10-05
Last updated by the study team: 2023-12-04

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥21 years of age (no upper age limit)
Histological or cytological documentation of metastatic adenocarcinoma of the colon or rectum. Biopsy of primary tumor alone is adequate if the patient has clear evidence of metastatic disease and/or elevated Carcinoembryonic antigen (CEA) and the treating physician does not feel biopsy of metastatic disease is clinically warranted.
Prior therapy with oxaliplatin and a fluoropyrimidine is required. One prior line of therapy with irinotecan is allowed. Prior therapy with an anti-Epidermal Growth Factor Receptor (EGFR) agent is also allowed.
Life expectancy of at least 3 months in opinion of treating investigator
Eastern Cooperative Oncology Group performance status ≤1 (Appendix B)
Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of treatment initiation with curcumin:
absolute neutrophil count (ANC) ≥1,500/mm3
platelets ≥100,000/mm3
hemoglobin ≥9.0 g/dL
serum creatinine ≤1.5 x upper limit of normal (ULN)
aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
Total bilirubin ≤ 1.5 x ULN
Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
Medical oncologist agrees that four day window on curcumin alone is appropriate/safe prior to start of irinotecan for trial candidate.
The subject is capable of understanding and complying with parameters as outlined in the protocol
Signed, Institutional Review Board(IRB)-approved written informed consent

You may not qualify if…

Any prior allergies to curcumin or turmeric.
Prior intolerance of irinotecan or necessity for dose reduction greater than 20%
Patients who are already known homozygous for the UGT1A1*28 allele (UDP-glucuronosyltransferase 1-1*28), and patients of Asian descent homozygous or heterozygous for the UGT1A1*6 allele will be excluded due to their altered irinotecan metabolism
Pregnant or breastfeeding patients. Women of childbearing potential must have a documented negative pregnancy test a maximum of 7 days before start of treatment.
History of Gilbert's syndrome
Active cardiac disease including any of the following:
Congestive heart failure ≥Class 2 according to New York Heart Association [NYHA] (see Appendix C)
Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of Day 1 of irinotecan.
Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Ongoing infection > Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
Known history of human immunodeficiency virus (HIV) infection
Symptomatic metastatic brain or meningeal tumors unless the patient is >3 months from definitive therapy, has a negative imaging study within 4 weeks of irinotecan initiation, and is clinically stable with respect to the tumor at the time of study entry. Also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to D1 of treatment under this study)
Inability to swallow oral medications or any malabsorption condition
Patients with diarrhea CTCAE v4 grade ≥2
Unresolved toxicity higher than CTCAE v. 4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin-induced neurotoxicity (which must be ≤ Grade 2)
Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Patients unwilling or unable to refrain from use of moderate or strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) (Appendix A)

Where it is running

IU Simon Cancer Center — Indianapolis, Indiana, United States
University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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