Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L)
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
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: December 20, 2012
Last verified: December 2012
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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) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Evaluation of measurable tumor: the same imaging technique used during the initial evaluation or more sophisticated studies will be performed once every 8 weeks or sooner if clinically indicated.
| Estimated Enrollment: | 72 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2019 (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:
- 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 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 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.
Exclusion Criteria:
- 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).
- 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.
Contacts and Locations
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: | December 20, 2012 |
| 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 May 22, 2013