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Trial record 31 of 483 for:    colon cancer | ( Map: Texas, United States )

Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02316340
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Vorinostat Drug: Hydroxychloroquine Drug: Regorafenib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modulation of Autophagy: A Clinical Study of Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Refractory Metastatic Colorectal Cancer (mCRC) Patients (CTMS# 14-2015)
Study Start Date : February 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Arm - VOR with HCQ
Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
Drug: Vorinostat
400mg by mouth daily
Other Names:
  • Zolinza
  • SAHA
  • VOR

Drug: Hydroxychloroquine
600mg by mouth daily
Other Names:
  • HCQ
  • plaquenil

Active Comparator: Control Arm - Regorafenib
Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.
Drug: Regorafenib
160 mg by mouth daily
Other Names:
  • Stivarga
  • RGF




Primary Outcome Measures :
  1. Efficacy based on progression free survival of vorinostat and hydroxychloroquine compared to Regorafenib [ Time Frame: Every 8 weeks ]
    CT Scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of metastatic colorectal cancer (mCRC)
  • ECOG performance status of 0-2
  • Radiographical documentation of metastatic disease with imaging up to 6 weeks prior to enrollment
  • Patients with mCRC must have been previously treated with irinotecan and/or oxaliplatin and/or VEGF/EGFR therapy or intolerant to these agents
  • Documentation of K-Ras mutational status
  • Adequate hematologic, renal and liver function (i.e. absolute neutrophil count > 1000/mm3, platelets > 75,000/mm3); creatinine < 2 times the upper limits of normal (ULN) total bilirubin < 1.5 mg/dl, ALT and AST< 3 times above the ULN, ALT and AST can be < 5 times ULN if patients have hepatic involvement.
  • Able to provide written informed consent
  • Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
  • Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy

Exclusion Criteria:

  • Patients receiving prior therapy with RGF, VOR, and/or HCQ
  • Patients with uncontrolled brain metastases. Patients with brain metastases must be asymptomatic and off corticosteroids for at least one week
  • Due to risk of disease exacerbation, patients with porphyria are not eligible
  • Due to risk of disease exacerbation, patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
  • Patients with previously documented macular degeneration or diabetic retinopathy
  • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. For targeted therapies, patients will need to clear for 5 half-lives
  • Patients may not be receiving any other investigational agents
  • Patients should not have taken valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to enrollment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to VOR or HCQ
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Major surgery or significant traumatic injury occurring within 21 days prior to treatment
  • QTc > 500 ms at baseline (average of 3 determinations at 10 minutes interval)
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Patients with NG-tube, J-tube, or G-tube will not be allowed to participate
  • Pregnant women are excluded from this study because vorinostat has the potential for teratogenic or abortifacient effects. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued
  • Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document will be excluded from study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316340


Locations
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United States, Texas
Cancer Therapy and Research Center University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Sukeshi Patel Arora, MD University of Texas Health Science Center at the Cancer Therapy and Research Center

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02316340     History of Changes
Other Study ID Numbers: CTMS 14-2015
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Hydroxychloroquine
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents