Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01859858
Eligibility Criteria:
Inclusion Criteria
1. Age ≥21 years of age (no upper age limit)
2. 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.
3. 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.
4. Life expectancy of at least 3 months in opinion of treating investigator
5. Eastern Cooperative Oncology Group performance status ≤1 (Appendix B)
6. 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
7. 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.
8. Medical oncologist agrees that four day window on curcumin alone is appropriate/safe prior to start of irinotecan for trial candidate.
9. The subject is capable of understanding and complying with parameters as outlined in the protocol
10. Signed, Institutional Review Board(IRB)-approved written informed consent
Exclusion Criteria:
1. Any prior allergies to curcumin or turmeric.
2. Prior intolerance of irinotecan or necessity for dose reduction greater than 20%
3. 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
4. Pregnant or breastfeeding patients. Women of childbearing potential must have a documented negative pregnancy test a maximum of 7 days before start of treatment.
5. History of Gilbert's syndrome
6. 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)
7. Ongoing infection \> Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
8. Known history of human immunodeficiency virus (HIV) infection
9. 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)
10. Inability to swallow oral medications or any malabsorption condition
11. Patients with diarrhea CTCAE v4 grade ≥2
12. 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)
13. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
14. 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT01859858
Study Brief:
Protocol Section:
NCT01859858