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

This study has been completed.
Sponsor:
Collaborators:
Gateway for Cancer Research
Theravalues, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01201694
First received: September 9, 2010
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Advanced Cancers
Drug: Surface-Controlled Water Soluble Curcumin
Drug: Surface-Controlled Water Soluble Curcumin MTD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Surface-Controlled Water Dispersible Curcumin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 28
Study Start Date: October 2011
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201694

Locations
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.
Investigators
Principal Investigator: David S. Hong, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01201694     History of Changes
Other Study ID Numbers: 2010-0276
Study First Received: September 9, 2010
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced malignancies
Surface-controlled water soluble curcumin
Turmeric
Dietary supplements

Additional relevant MeSH terms:
Neoplasms
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014