A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors

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

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

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 refractory solid tumors.

Detailed Description

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Conditions

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Neoplasms

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

5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* \> or = 18 years of age
* Advanced or metastatic solid tumors:

Part 1: Histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists

Part 2: Histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

* Radiologically documented measurable or evaluable (non-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

* Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
* Non-cytotoxic cancer therapy within 14 days prior to study entry
* 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
* 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

Responsible Party

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Adherex Technoloogies

Principal Investigators

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Howard Burris, III, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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Adherex Protocol # AHX-03-104

Identifier Type: -

Identifier Source: org_study_id