Study of Curcumin, Vorinostat, and Sorafenib

Advanced Cancers Clinical Trial

Official title: Pilot Study of Curcumin, Vorinostat, and Sorafenib in Patients With Advanced Solid Tumors

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn the highest tolerable dose of the combination of curcumin, vorinostat, and sorafenib that can be given to patients with advanced solid cancer. The safety of this drug combination will also be studied.

Clinical Trial 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 in the laboratory and in clinical trials.

Vorinostat is designed to cause chemical changes in different kinds of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.

Sorafenib is designed to block the ability of important proteins to activate in cancer cells. These proteins, when active, are in part responsible for the abnormal growth and behavior of cancer cells. Blocking their activity may slow the growth of the cancer cells or cause the cancer cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drug combination (curcumin, vorinostat, and sorafenib) based on when you joined this study. Up to 9 dose levels of the study drug combination will be tested.

Three (3) to 6 participants will be enrolled at each dose level of the study drug combination. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

The dose of the study drug combination that you receive may be lowered if you experience any intolerable side effects. You will not receive any doses of the study drug combination higher than the dose level that you are first assigned.

Study Drug Administration:

For the purposes of this study, a study drug "cycle" is 28 days long.

Starting on Day 1 of Cycle 1, you will begin taking curcumin 1 time daily.

Starting on Day 3 of Cycle 1, you will being taking vorinostat 1 time daily.

Starting on Day 5 of Cycle 1, you will begin taking sorafenib 1-2 times daily depending on the dose level you are assigned to. From this day forward, you will continue to take the study drug combination every day of each cycle.

Curcumin is a powder that comes in a paper packet, and you will take it by mouth with a full glass of water (8 oz.). Vorinostat and sorafenib are capsules that you will take by mouth. Vorinostat should be taken with food. Sorafenib should be taken without food. The capsules should be swallowed whole. You should not break, chew, or open the capsules.

Baseline Tests:

The following tests and procedures will be performed within 7 days before the first dose of the study drug combination (Day 1 of Cycle 1):

• You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, breathing rate, heart rate, and temperature).

• You will be asked how well you are able to perform the normal activities of daily living (a performance status).

• Blood (about 2 teaspoons) will be drawn for routine tests.

• Urine will be collected for routine tests.

• You will have an echocardiogram (ECHO) to check your heart function.

• Women who are able to become pregnant must have a negative blood (about 1 teaspoon) pregnancy test. In order to continue your participation in this study, the pregnancy test must be negative.

Study Visits:

Every week while you are receiving the study drug combination, blood (about 2 teaspoons) will be drawn for routine tests.

Before you begin each cycle, the following tests and procedures will be performed:

• 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 have an ECG.

• Urine will be collected for routine tests.

• You will be asked about any side effects you may be experiencing.

At the end of every 2 cycles (Cycles 2, 4, 6, and so on):

• 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 more appropriate for you, additional types of scans not listed in this consent form may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form that will explain the details and risks of those scans.

• If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.

Length of Study:

You may remain on study for as long as the study doctor thinks you are benefitting from the study drugs. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or the study doctor thinks it is in your best interest.

End-of-Study Visit:

Within 30 days after your last dose of the study drug combination, you will come back to the hospital for an end-of-study visit and the following tests and procedures performed:

• 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.

• Urine will be collected for routine tests.

• You will be asked about any side effects you may be experiencing.

• 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 more appropriate for you, additional types of scans not listed in this consent form may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form that will explain the details and risks of those 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 the treatment of advanced solid cancer. At this time, curcumin is only being used in research. Vorinostat is FDA approved and commercially available for the treatment of T-cell lymphoma. Sorafenib is FDA approved and commercially available for the treatment of liver and renal cancer. At this time, the combination of curcumin, vorinostat, and sorafenib is only being used in research.

Up to 96 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancers

• NCT number: NCT01608139
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 2012