NCT02316340

Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

Modulation of Autophagy: A Clinical Study of Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Refractory Metastatic Colorectal Cancer (mCRC) Patients (CTMS# 14-2015)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized phase II clinical trial of patients with histologic documentation of metastatic colorectal cancer, who have received local and currently approved standard therapies, excluding RGF.

Detailed description

The investigators will give VOR 400 mg PO daily and HCQ 600 mg PO daily in 4-week cycles. Patients will require imaging up to 6 weeks prior to enrollment and will be assessed for measureable evidence of mCRC. This will be a randomized, controlled phase II clinical trial of patients with histological documentation of metastatic colorectal cancer, who have received locally and currently approved standard therapies, excluding RGF. Patients will be randomized 1:1 to RGF or VOR/HCQ (see schema below). Also, crossover is optional after first progression on the initial therapy, and based on physician discretion and in the best interest of the patient. If crossover is not done, then the patient will be off study and can go on to receive other treatments.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Vorinostat	400mg by mouth daily
DRUG	Hydroxychloroquine	600mg by mouth daily
DRUG	Regorafenib	160 mg by mouth daily

Timeline

• Start date: 2015-02-11
• Primary completion: 2018-03-07
• Completion: 2018-04-16
• First posted: 2014-12-12
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States