Advanced Colorectal CancerPhase 1NCT01859858
Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors
A Phase 1 study testing curcumin and Irinotecan in people with Advanced Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- curcumin and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to 5 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
Show all 17Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center
Chapel Hill, North Carolina, 27509
IU Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Prospective Evaluation of the Effect of Curcumin on Dose-limiting Toxicity and Pharmacokinetics of Irinotecan in Colorectal Cancer Patients
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.
Read the detailed description
Treatment Plan
This is a single-center, two-part, open label prospective study to define the maximum tolerated dose (MTD) of curcumin plus irinotecan and the pharmacokinetic effects of curcumin on irinotecan metabolism in patients with advanced colorectal cancer. Each cycle of irinotecan is defined as 28 days, with a dose of irinotecan administered on D1 and D15. The study will have two parts: Part 1 comprises the dose escalation portion of the study and Part 2 comprises the MTD expansion and pharmacokinetic study.
Patients will be recruited from the GI oncology clinic of the North Carolina Cancer Hospital. After obtaining informed consent, patients will be entered into Part 1 of the study until the MTD has been defined. During study Part 1, patients will be given a 4 day run-in of curcumin prior to irinotecan dosing. The planned dose levels of curcumin will be 1, 2, 3, and 4 grams per day. Irinotecan will be dosed at 200 mg/m2 IV on days 1 and 15.46 Additional antineoplastic agents will not be allowed during the trial. Two patients will be enrolled at each dose level until a DLT occurs, beginning with the lowest dose level and increasing the level only after 2 patients have successfully completed a full irinotecan cycle at that dose level.
Part 2 will investigate the effect of curcumin on irinotecan and SN-38 pharmacokinetics. We will expand the cohort of patients at the defined MTD in part 1. Patients will receive irinotecan alone for a single dose (D1). Curcumin, at the MTD, will be started on D11 and continued until the end of the cycle (D28). Irinotecan will be administered again on D15.
Blood samples will be collected on the days of irinotecan infusion (D1 and D15) as follows: prior to treatment with irinotecan (baseline), immediately following the end of irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion for irinotecan and SN-38 PK.
All patients will continue on curcumin + irinotecan for further cycles until disease progression or toxicity occurs at the discretion of the treating physician (see section 5.6). For patients in study Part 1, we will offer to escalate the curcumin dose to the highest dose level that has been safely completed until an MTD has been estimated.
Treatment Assignment Part 1:
At the end of the screening period, eligible patients are assigned in cohorts of 2 at escalating doses until the first Dose Limiting Toxicity(DLT) is observed. DLT determination will be made based on one cycle in initial cohorts of 2. As much information as possible is used in the initial cohorts of 2. After the first DLT is observed, DLT rates at each dose are estimated using isotonic regression. For that, proportions of DLTs are computed at each dose first, then, if there is a violation of monotonicity, data at the violating dose levels are pooled and new proportions computed. The estimated DLT rate at the current dose is used to determine whether the dose will be increased, decreased or remained unchanged. The dose is to remain unchanged if the estimated DLT rate at the current dose is between [0.17, 0.33]; the dose is decreased if the estimated DLT rate is higher than 0.33; and the dose is increased if the estimated DLT is lower than 0.17. Dose assignment will progress with successful completion of two participants at each dose level until DLT occurs. Dose assignment after the first DLT will be made in collaboration with the study statistician for each patient.
For Part 1, up to 20 patients will be assigned using the algorithm above. The MTD will be estimated when either the highest dose is reached with no DLTs or after 20 patients have completed the algorithm above.
Part 2: After the MTD has been estimated, 10 new patients will be assigned to the "expanded MTD cohort" to estimate PK parameters for irinotecan and SN-38 (active metabolite of irinotecan) with and without curcumin. . The "expanded MTD cohort" might have more than 10 patients if Part 1 sample size is smaller than 20, as long as the total number of patients in the trial does not exceed 30. The estimated MTD might be re-evaluated if the estimated DLT rate at that dose is outside [0.17, 0.33].
- Conditions
- Advanced Colorectal Cancer
- Being tested
- curcumin, Irinotecan
- Keywords
- mCRC (metastatic colorectal cancer), CRC (colorectal cancer), Advanced colorectal cancer, Metastatic colorectal cancer, Colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
Also called tumeric, Curcuma longa, Meriva
IrinotecanDrug
Also called Camptosar
| Study group | Role | What they receive |
|---|---|---|
| curcumin + irinotecan (part 1) | Experimental | Oral Curcumin (1, 2, 3,or 4 grams per day) for 4 days prior to irinotecan + 200 mg/m2 irinotecan IV, days 1 and 15 Receives: Dietary Supplement: curcumin; Drug: Irinotecan |
| curcumin + irinotecan (part 2) | Experimental | MTD oral Curcumin as determined in part 1 + 200 mg/m2 irinotecan IV, days 1 and 15 Receives: Dietary Supplement: curcumin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
During Part 1 of study dose escalation will be used to determine the MTD of curcumin based on a DLT rate of 0.25 for the combination with irinotecan.
Measured: 28 days
Pharmacokinetics of irinotecan
The effect of curcumin on irinotecan PK will be evaluated via measurement of plasma Area Under the Curve (AUC) for irinotecan, with and without concomitant curcumin.
Measured: 28 days
Pharmacokinetics of SN-38
The effect of curcumin on SN-38 PK will be evaluated via measurement of plasma AUC of SN-38, with and without concomitant curcumin.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2013
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Asher, MD, MPH, Principal investigator, University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859858
- Sponsor's protocol ID
- LCCC 1227
- Status last verified
- Jun 2020
- First submitted
- 17 May 2013
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Effect of Curcumin on Dose-limiting Toxicity and Pharmacokinetics of Irinotecan in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01859858
- Acronym / sponsor ID
- LCCC 1227
- Conditions
- Advanced Colorectal Cancer
- Keywords
- mCRC (metastatic colorectal cancer), CRC (colorectal cancer), Advanced colorectal cancer, Metastatic colorectal cancer, Colon cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment Plan
This is a single-center, two-part, open label prospective study to define the maximum tolerated dose (MTD) of curcumin plus irinotecan and the pharmacokinetic effects of curcumin on irinotecan metabolism in patients with advanced colorectal cancer. Each cycle of irinotecan is defined as 28 days, with a dose of irinotecan administered on D1 and D15. The study will have two parts: Part 1 comprises the dose escalation portion of the study and Part 2 comprises the MTD expansion and pharmacokinetic study.
Patients will be recruited from the GI oncology clinic of the North Carolina Cancer Hospital. After obtaining informed consent, patients will be entered into Part 1 of the study until the MTD has been defined. During study Part 1, patients will be given a 4 day run-in of curcumin prior to irinotecan dosing. The planned dose levels of curcumin will be 1, 2, 3, and 4 grams per day. Irinotecan will be dosed at 200 mg/m2 IV on days 1 and 15.46 Additional antineoplastic agents will not be allowed during the trial. Two patients will be enrolled at each dose level until a DLT occurs, beginning with the lowest dose level and increasing the level only after 2 patients have successfully completed a full irinotecan cycle at that dose level.
Part 2 will investigate the effect of curcumin on irinotecan and SN-38 pharmacokinetics. We will expand the cohort of patients at the defined MTD in part 1. Patients will receive irinotecan alone for a single dose (D1). Curcumin, at the MTD, will be started on D11 and continued until the end of the cycle (D28). Irinotecan will be administered again on D15.
Blood samples will be collected on the days of irinotecan infusion (D1 and D15) as follows: prior to treatment with irinotecan (baseline), immediately following the end of irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion for irinotecan and SN-38 PK.
All patients will continue on curcumin + irinotecan for further cycles until disease progression or toxicity occurs at the discretion of the treating physician (see section 5.6). For patients in study Part 1, we will offer to escalate the curcumin dose to the highest dose level that has been safely completed until an MTD has been estimated.
Treatment Assignment Part 1:
At the end of the screening period, eligible patients are assigned in cohorts of 2 at escalating doses until the first Dose Limiting Toxicity(DLT) is observed. DLT determination will be made based on one cycle in initial cohorts of 2. As much information as possible is used in the initial cohorts of 2. After the first DLT is observed, DLT rates at each dose are estimated using isotonic regression. For that, proportions of DLTs are computed at each dose first, then, if there is a violation of monotonicity, data at the violating dose levels are pooled and new proportions computed. The estimated DLT rate at the current dose is used to determine whether the dose will be increased, decreased or remained unchanged. The dose is to remain unchanged if the estimated DLT rate at the current dose is between [0.17, 0.33]; the dose is decreased if the estimated DLT rate is higher than 0.33; and the dose is increased if the estimated DLT is lower than 0.17. Dose assignment will progress with successful completion of two participants at each dose level until DLT occurs. Dose assignment after the first DLT will be made in collaboration with the study statistician for each patient.
For Part 1, up to 20 patients will be assigned using the algorithm above. The MTD will be estimated when either the highest dose is reached with no DLTs or after 20 patients have completed the algorithm above.
Part 2: After the MTD has been estimated, 10 new patients will be assigned to the "expanded MTD cohort" to estimate PK parameters for irinotecan and SN-38 (active metabolite of irinotecan) with and without curcumin. . The "expanded MTD cohort" might have more than 10 patients if Part 1 sample size is smaller than 20, as long as the total number of patients in the trial does not exceed 30. The estimated MTD might be re-evaluated if the estimated DLT rate at that dose is outside [0.17, 0.33].
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcumin + irinotecan (part 1) | Experimental | Dietary Supplement: curcumin, Drug: IrinotecanOral Curcumin (1, 2, 3,or 4 grams per day) for 4 days prior to irinotecan + 200 mg/m2 irinotecan IV, days 1 and 15 |
| curcumin + irinotecan (part 2) | Experimental | Dietary Supplement: curcumin, Drug: IrinotecanMTD oral Curcumin as determined in part 1 + 200 mg/m2 irinotecan IV, days 1 and 15 |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcuminAlso: tumeric, Curcuma longa, Meriva | Dietary supplement | curcumin + irinotecan (part 1), curcumin + irinotecan (part 2) |
| IrinotecanAlso: Camptosar | Drug | curcumin + irinotecan (part 1), curcumin + irinotecan (part 2) |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 28 days
During Part 1 of study dose escalation will be used to determine the MTD of curcumin based on a DLT rate of 0.25 for the combination with irinotecan.
Pharmacokinetics of irinotecan
Time frame: 28 days
The effect of curcumin on irinotecan PK will be evaluated via measurement of plasma Area Under the Curve (AUC) for irinotecan, with and without concomitant curcumin.
Pharmacokinetics of SN-38
Time frame: 28 days
The effect of curcumin on SN-38 PK will be evaluated via measurement of plasma AUC of SN-38, with and without concomitant curcumin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- UNC Lineberger WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Asher, MD, MPH principal investigator
University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing curcumin and Irinotecan in people with Advanced Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.