Study of Curcumin, Vorinostat, and Sorafenib
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Curcumin, Vorinostat, and Sorafenib in Patients With Advanced Solid Tumors|
- Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined by dose limiting toxicities (DLTs) that occur in the first cycle. Hematological DLT defined as platelets less than 25,000/uL or bleeding associated with platelets less than 50,000/uL, ANC less than 500/uL for more than 7 days, neutropenic fever, hemoglobin less than 6.5 g/dL, or more than 14 days of delay in initiation of subsequent treatment because of inadequate hematological parameters. Nonhematological toxicities graded by using NCI CTCAE v4.0 toxicity criteria.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2022 (Final data collection date for primary outcome measure)|
Experimental: Curcumin + Sorafenib + Vorinostat
Participant assigned to a dose level of the study drug combination based on when 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. During first cycle only, Curcumin initiated on Day 1, Vorinostat on Day 3 and Sorafenib on Day 5. Beginning with Cycle 1 Day 5, all agents administered continuously. Cycle of therapy is 28 days.
Starting dose of Curcumin: 4 grams by mouth per day on Day 1. Starting dose of Sorafenib: 200 mg by mouth daily beginning on Day 5. Starting dose of Vorinostat: 100 mg by mouth daily beginning on Day 3.
Starting dose: 4 grams by mouth per day. During the first cycle only, Curcumin given on Day 1. Beginning with Cycle 1 Day 5, all agents will be administered continuously.Drug: Sorafenib
Starting dose: 200 mg by mouth daily. During the first cycle only, Sorafenib given on Day 5. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
Other Names:Drug: Vorinostat
Starting dose: 100 mg by mouth daily. During the first cycle only, Vorinostat given on Day 3. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01608139
|Principal Investigator:||David S. Hong, MD||UT MD Anderson Cancer Center|