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

NCT01201694 | Completed Phase 1

• 1 other identifier: 2010-0276
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancers

Keywords

Advanced malignancies; Surface-controlled water soluble curcumin; Turmeric; Dietary supplements

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks

Study Arms (2)

Surface-Controlled Water Soluble Curcumin Group

EXPERIMENTAL

Starting dose 100 mg by mouth two times a day of a 28 day cycle.

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

Drug: Surface-Controlled Water Soluble Curcumin MTD

Interventions

Surface-Controlled Water Soluble Curcumin DRUG

Starting dose 100 mg by mouth two times a day of a 28 day cycle.

Surface-Controlled Water Soluble Curcumin Group

Surface-Controlled Water Soluble Curcumin MTD DRUG

Dose will be maximum tolerated dose (MTD) from Arm 1.

Surface-Controlled Water Soluble Curcumin Expansion

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gateway for Cancer Research: collaborator
• Theravalues, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Study Officials

• David S. Hong, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 14, 2010
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (1)