Advanced CancersPhase 1NCT01201694
Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L)
A Phase 1 study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable doses of surface-controlled water dispersible curcumin (curcumin) that can be given to patients with advanced cancer. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Advanced Cancers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2014
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have an advanced malignancy that has either failed one or more prior therapies, or for which there is no established standard of care therapy that improves survival by at least 3 months. If standard therapies are available, the informed consent states that patients are forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).
- Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > 1,000 /uL Platelets > 50,000 /uL Total bilirubin </= 1.5 x upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) and ALT </= 3 x ULN, Creatinine </= 1.5 x ULN or creatinine clearance >/= 40 ml/min
- Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.
- Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., barrier device) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
- Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.
- Men and women aged >/= 18 years. However, patients who are 13 years or older will be eligible after consultation with their pediatric attending.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, active bleeding that requires hospitalization, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject that has not recovered from major surgical procedure, open biopsy, or significant traumatic injury (i.e. subject still needs additional medical care for these issues).
- History of gastric or duodenal ulcers, or hyperacidity syndromes.
- History of allergic reactions to the study drug or its analogs.
- Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).
- Currently taking therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (any prophylaxis agents are acceptable).
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- International normalized ratio (INR) > 1.5
- Biliary obstruction or cholelithiasis.
- Inability to take oral medication (PEG tube is acceptable).
- Pregnant or breastfeeding women.
- Concurrent enrollment on another therapeutic research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable doses of surface-controlled water dispersible curcumin (curcumin) that can be given to patients with advanced cancer. The safety of this drug will also be studied.
Read the detailed description
The Study Drugs:
Curcumin is the active ingredient in the spice, turmeric. It is a natural anti-inflammatory compound and has shown anti-tumor activity. Surface-controlled water dispersible curcumin is designed to be better absorbed by the body than regular curcumin.
Study Groups:
The first group of participants will receive the lowest dose level. Each new group will usually receive a higher dose than the group before it, if no intolerable side effects were seen. Each group will have 3-6 participants. This will continue until the highest tolerable dose of curcumin is found. Up to 6 dose levels of curcumin will be tested. Once the highest tolerable dose of each arm is found, up to 14 extra participants will be enrolled for extra safety testing.
In some cases, extra participants may be enrolled at dose levels shown to be safe for extra safety and/or pharmacokinetic (PK) and pharmacodynamic (PD) testing.
You will be assigned to a dose level based on when you join this study.
The dose of the study drug that you receive may be lowered if you have any intolerable side effects. If you are tolerating the treatment, your study drug dose may be increased after the first cycle to the highest dose level shown to be safe.
Study Drug Administration:
Each study "cycle" is 28 days long.
You will take 1 dose of curcumin on Day 1 of Cycle 1. Starting on Day 2 of Cycle 1, you will begin taking curcumin 2 times each day.
Curcumin is a liquid that comes in a bottle, and you will take it by mouth on an empty stomach with a full glass of water (8 ounces). If you are not tolerating the doses and your doctor thinks it is needed, you may take curcumin in divided doses several times a day with food.
Study Visits:
Before your first dose of study drug and during Week 2 of Cycle 2, you will complete a questionnaire about your quality of life. It should take about 5-10 minutes to complete.
Every week of Cycle 1 and then as often as the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
Before you begin each cycle:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
At the end of Cycle 2 and then every 2-3 cycles:
- You will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease. If the study doctor thinks it is needed, these scan may be performed more often. You also may have extra types of scans not listed in this consent form.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
PK Testing:
Blood (about ½ teaspoon each time) will be drawn for PK testing at the following times:
- On Day 1 of Cycle 1, blood will be drawn before the dose and then 6 more times over the next 6 hours after the dose.
- On Day 2 of Cycle 1, blood will be drawn 1 time.
Length of Study:
You may remain on study for as long as the study doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of the study drug(s), you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease. If the study doctor thinks it is needed, you may also have extra types of scans.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Curcumin is not FDA approved for any usage. At this time, curcumin is only being used in research.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Surface-Controlled Water Soluble Curcumin, Surface-Controlled Water Soluble Curcumin MTD
- Keywords
- Advanced malignancies, Surface-controlled water soluble curcumin, Turmeric, Dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface-Controlled Water Soluble CurcuminDrug
Starting dose 100 mg by mouth two times a day of a 28 day cycle.
Surface-Controlled Water Soluble Curcumin MTDDrug
Dose will be maximum tolerated dose (MTD) from Arm 1.
| Study group | Role | What they receive |
|---|---|---|
| Surface-Controlled Water Soluble Curcumin Group | Experimental | Starting dose 100 mg by mouth two times a day of a 28 day cycle. Receives: Drug: Surface-Controlled Water Soluble Curcumin |
| Surface-Controlled Water Soluble Curcumin Expansion | Experimental | Following finding of MTD surface-controlled water soluble curcumin, escalating dose levels Receives: Drug: Surface-Controlled Water Soluble Curcumin MTD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Surface-Controlled Water Dispersible Curcumin
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as treatment-related grade 3 or greater non-hematological toxicity other than nausea, vomiting, drug-related grade 3 or greater electrolyte abnormalities that do not return to ≤ grade 1 or baseline within 72 hours, or grade 3 nausea and vomiting related to study drug treatment that is not controlled at 72 hours despite appropriate antiemetic therapy. The defined events will be considered as DLT if they occur within the first cycle (28 days).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research, Theravalues, Inc.
- Responsible party
- Sponsor
- Investigators
- David S. Hong, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201694
- Sponsor's protocol ID
- 2010-0276
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2010
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01201694
- Acronym / sponsor ID
- 2010-0276
- Conditions
- Advanced Cancers
- Keywords
- Advanced malignancies, Surface-controlled water soluble curcumin, Turmeric, Dietary supplements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research, Theravalues, Inc.
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Sep 2010 (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.
The goal of this clinical research study is to find the highest tolerable doses of surface-controlled water dispersible curcumin (curcumin) that can be given to patients with advanced cancer. The safety of this drug will also be studied.
Detailed description
The Study Drugs:
Curcumin is the active ingredient in the spice, turmeric. It is a natural anti-inflammatory compound and has shown anti-tumor activity. Surface-controlled water dispersible curcumin is designed to be better absorbed by the body than regular curcumin.
Study Groups:
The first group of participants will receive the lowest dose level. Each new group will usually receive a higher dose than the group before it, if no intolerable side effects were seen. Each group will have 3-6 participants. This will continue until the highest tolerable dose of curcumin is found. Up to 6 dose levels of curcumin will be tested. Once the highest tolerable dose of each arm is found, up to 14 extra participants will be enrolled for extra safety testing.
In some cases, extra participants may be enrolled at dose levels shown to be safe for extra safety and/or pharmacokinetic (PK) and pharmacodynamic (PD) testing.
You will be assigned to a dose level based on when you join this study.
The dose of the study drug that you receive may be lowered if you have any intolerable side effects. If you are tolerating the treatment, your study drug dose may be increased after the first cycle to the highest dose level shown to be safe.
Study Drug Administration:
Each study "cycle" is 28 days long.
You will take 1 dose of curcumin on Day 1 of Cycle 1. Starting on Day 2 of Cycle 1, you will begin taking curcumin 2 times each day.
Curcumin is a liquid that comes in a bottle, and you will take it by mouth on an empty stomach with a full glass of water (8 ounces). If you are not tolerating the doses and your doctor thinks it is needed, you may take curcumin in divided doses several times a day with food.
Study Visits:
Before your first dose of study drug and during Week 2 of Cycle 2, you will complete a questionnaire about your quality of life. It should take about 5-10 minutes to complete.
Every week of Cycle 1 and then as often as the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
Before you begin each cycle:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
At the end of Cycle 2 and then every 2-3 cycles:
- You will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease. If the study doctor thinks it is needed, these scan may be performed more often. You also may have extra types of scans not listed in this consent form.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
PK Testing:
Blood (about ½ teaspoon each time) will be drawn for PK testing at the following times:
- On Day 1 of Cycle 1, blood will be drawn before the dose and then 6 more times over the next 6 hours after the dose.
- On Day 2 of Cycle 1, blood will be drawn 1 time.
Length of Study:
You may remain on study for as long as the study doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of the study drug(s), you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease. If the study doctor thinks it is needed, you may also have extra types of scans.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Curcumin is not FDA approved for any usage. At this time, curcumin is only being used in research.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surface-Controlled Water Soluble Curcumin Group | Experimental | Drug: Surface-Controlled Water Soluble CurcuminStarting dose 100 mg by mouth two times a day of a 28 day cycle. |
| Surface-Controlled Water Soluble Curcumin Expansion | Experimental | Drug: Surface-Controlled Water Soluble Curcumin MTDFollowing finding of MTD surface-controlled water soluble curcumin, escalating dose levels |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have an advanced malignancy that has either failed one or more prior therapies, or for which there is no established standard of care therapy that improves survival by at least 3 months. If standard therapies are available, the informed consent states that patients are forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).
- Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > 1,000 /uL Platelets > 50,000 /uL Total bilirubin </= 1.5 x upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) and ALT </= 3 x ULN, Creatinine </= 1.5 x ULN or creatinine clearance >/= 40 ml/min
- Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.
- Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., barrier device) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
Key exclusion criteria (11 listed)
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, active bleeding that requires hospitalization, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject that has not recovered from major surgical procedure, open biopsy, or significant traumatic injury (i.e. subject still needs additional medical care for these issues).
- History of gastric or duodenal ulcers, or hyperacidity syndromes.
- History of allergic reactions to the study drug or its analogs.
- Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).
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 |
|---|---|---|
| Surface-Controlled Water Soluble CurcuminStarting dose 100 mg by mouth two times a day of a 28 day cycle. | Drug | Surface-Controlled Water Soluble Curcumin Group |
| Surface-Controlled Water Soluble Curcumin MTDDose will be maximum tolerated dose (MTD) from Arm 1. | Drug | Surface-Controlled Water Soluble Curcumin Expansion |
Primary outcome
Maximum Tolerated Dose (MTD) of Surface-Controlled Water Dispersible Curcumin
Time frame: 4 weeks
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as treatment-related grade 3 or greater non-hematological toxicity other than nausea, vomiting, drug-related grade 3 or greater electrolyte abnormalities that do not return to ≤ grade 1 or baseline within 72 hours, or grade 3 nausea and vomiting related to study drug treatment that is not controlled at 72 hours despite appropriate antiemetic therapy. The defined events will be considered as DLT if they occur within the first cycle (28 days).
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 8 Jan 2015.
- University of Texas MD Anderson Cancer Center 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.
David S. Hong, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site 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 7 inclusion and 11 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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) of Surface-Controlled Water Dispersible Curcumin (time frame: 4 weeks). 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 8 Jan 2015.