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Vorinostat and IV Fluorouracil/Leucovorin (5FU/LV) in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Vorinostat and IV Fluorouracil/Leucovorin (5FU/LV) in Patients With Metastatic Colorectal Cancer

Phase I/II Clinical Trial With Vorinostat and Infusional 5-FU/LV in Patients With Metastatic Colorectal Cancer Who Failed 5-FU-Based Chemotherapy

NCT00336141•University of Southern California

View on ClinicalTrials.gov

Summary

This protocol will investigate the use of vorinostat (suberoylanilide hydroxamic acid - SAHA) in combination with infusional 5-FU and leucovorin for the treatment of metastatic colorectal cancer patients who have failed standard 5FU regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed advanced/metastatic colorectal cancer.
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as \> 10 mm with spiral CT scan.
•Patients must have received prior therapy (in any setting) with 5-FU, CPT-11, and oxaliplatin. Patients may have received prior erbitux and bevacizumab, but it is not required.
•Patients must have received at least one prior chemotherapy regimen for advanced disease.
•Tumor must be accessible for core biopsy at the beginning of treatment and patients have a high intratumoral TS expression level prior to the beginning of treatment.
•Age \> 18 years. Because no dosing or AE data are currently available on the use of vorinostat in patients greater than 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
•Life expectancy of \> 12 weeks.
•ECOG performance status 0-2 (Karnofsky \> 50%; see Appendix A).
•Patients must have normal organ and marrow function as defined below:
•leukocytes \> 3,000/µL
+15 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from AEs due to agents administered more than 4 weeks earlier.
•Patients may not have received any other investigational agents within 28 days of study entry.
•Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study.
•Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat. These compounds include sodium butyrate, trichostatin A (TSA), trapoxin (TPX), MS-27-275 and depsipeptide.
•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.
•Pregnant women are excluded from this study because vorinostat is a HDAC inhibitor agent with an unknown potential for teratogenesis. 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 before the mother is treated with study therapy.
•Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with vorinostat. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
•Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤ 10 mg/day prednisone during the 4 weeks prior to the start of the study drugs.
•Patient has had an acute infection requiring intravenous antibiotic, antiviral, or antifungal medications within 2 weeks prior to the start of study drugs.
+4 more criteria

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

June 1, 2006

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

May 21, 2014

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Suberoylanilide hydroxamic acid

DRUG

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vorinostat and IV Fluorouracil/Leucovorin (5FU/LV) in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease