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

NCT00264472 | Suspended Phase 1

• 1 other identifier: Adherex Protocol # AHX-03-104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Part 1: To determine the DLTs and MTD of the combination of ADH300004 and 5 FU administered orally in a weekly regimen, for 3 weeks with 1 week rest per cycle, in subjects with incurable solid tumors

  4 weeks

• Part 2: To determine the DLTs and MTD of the combination of ADH300004 and 5-FU administered orally as a split dose for 3 out of 4 weeks in subjects with HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

  4 weeks

Interventions

ADH300004 DRUG

5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adherex Technologies, Inc.: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Links

• Adherex Technologies Inc. Corporate Homepage

MeSH Terms

Conditions

Neoplasms

Interventions

eniluracil

Study Officials

• Howard Burris, III, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Last Updated: December 15, 2008

Record last verified: 2008-12

Locations

US (1)