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A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma

NCT ID: NCT00319683

Last Updated: 2008-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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5-fluorouracil (5-FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will test the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Keywords

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Cancer Tumors Neoplasms Anticarcinogenic Agents Antineoplastic Agents Dihydrouracil Dehydrogenase (NADP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ADH300004

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* In the Phase I portion, Asian subjects that are \> or = to 18 years of age
* In the Phase II portion, any subjects that are \> or = to 18 years of age
* Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein \[AFP\] \> 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein \[AFP\] \> 400 ng/mL, hepatitis B surface antigen negative)
* Radiologically documented measurable disease
* Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
* Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study

Exclusion Criteria

* Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry
* No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy)
* Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
* Ascites that is refractory to conservative management
* Inability to take oral medication
* Active peptic ulcer disease
* Known hypersensitivity to 5-FU or ADH300004
* History of primary brain tumors or brain metastases
* Previous or concurrent malignancy at another site within the last 5 years
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adherex Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Adherex Technologies

Principal Investigators

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Jacqueline Whang-Peng, MD

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institute, Ward Veterans General Hospital

Locations

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Queens Medical Center

Honolulu, Hawaii, United States

Site Status

Johns Hopkins Singapore International Medical Center

Singapore, , Singapore

Site Status

Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status

National Health Research Institute, Ward Veterans General Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Singapore Taiwan

Related Links

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http://www.adherex.com

Adherex Technologies Inc. Corporate Homepage

Other Identifiers

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AHX-03-103

Identifier Type: -

Identifier Source: org_study_id