A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed written informed consent
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or = 18 years of age
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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
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Radiologically documented measurable or evaluable (non-measurable) disease
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Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
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Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study
Exclusion Criteria:
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Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
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Non-cytotoxic cancer therapy within 14 days prior to study entry
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Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
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Ascites that is refractory to conservative management
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Inability to take oral medication
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Active peptic ulcer disease
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Known hypersensitivity to 5-FU or ADH300004
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Stroke, major surgery, or other major tissue injury within 30 days before study entry
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Adherex Technologies, Inc.
Investigators
- Principal Investigator: Howard Burris, III, MD, SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Adherex Protocol # AHX-03-104