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Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01201694
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : January 8, 2015
Gateway for Cancer Research
Theravalues, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Surface-Controlled Water Soluble Curcumin Drug: Surface-Controlled Water Soluble Curcumin MTD Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies
Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Surface-Controlled Water Soluble Curcumin Group
Starting dose 100 mg by mouth two times a day of a 28 day cycle.
Drug: Surface-Controlled Water Soluble Curcumin
Starting dose 100 mg by mouth two times a day of a 28 day cycle.

Experimental: Surface-Controlled Water Soluble Curcumin Expansion
Following finding of MTD surface-controlled water soluble curcumin, escalating dose levels
Drug: Surface-Controlled Water Soluble Curcumin MTD
Dose will be maximum tolerated dose (MTD) from Arm 1.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).
  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
  4. Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.
  5. 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.
  6. Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.
  7. Men and women aged >/= 18 years. However, patients who are 13 years or older will be eligible after consultation with their pediatric attending.

Exclusion Criteria:

  1. 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.
  2. 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).
  3. History of gastric or duodenal ulcers, or hyperacidity syndromes.
  4. History of allergic reactions to the study drug or its analogs.
  5. 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).
  6. Currently taking therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (any prophylaxis agents are acceptable).
  7. International normalized ratio (INR) > 1.5
  8. Biliary obstruction or cholelithiasis.
  9. Inability to take oral medication (PEG tube is acceptable).
  10. Pregnant or breastfeeding women.
  11. Concurrent enrollment on another therapeutic research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01201694

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Gateway for Cancer Research
Theravalues, Inc.
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Principal Investigator: David S. Hong, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01201694    
Other Study ID Numbers: 2010-0276
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by M.D. Anderson Cancer Center:
Advanced malignancies
Surface-controlled water soluble curcumin
Dietary supplements
Additional relevant MeSH terms:
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Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action