A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors
This study has suspended participant recruitment.
(Lack of funds)
Sponsor:
Adherex Technologies, Inc.
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00264472
First received: December 12, 2005
Last updated: December 12, 2008
Last verified: December 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: ADH300004 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 2-Part Phase 1 Study Evaluating the Safety and Anti-Tumor Activity of ADH300004 (Eniluracil) Administered With 5-Fluorouracil (5-FU), and the Pharmacokinetics of 5-FU Given as: 5.0 mg ADH300004 With Escalating Doses of 5-FU Administered Orally 3 Weeks Out of 4 in Subjects With Refractory Solid Tumors (Part 1); or 5.0 mg ADH300004 With 5 FU Administered Orally as a Split Dose for 3 Weeks Out of 4 in Subjects With Hepatocellular Carcinoma, Non-Small Cell Lung Carcinoma, Gastric Cancer, Cervical Cancer, Prostate Cancer, or Breast Cancer (Part 2) (Adherex Protocol Number AHX-03-104) |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fluorouracil
U.S. FDA Resources
Further study details as provided by Adherex Technologies, Inc.:
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: ADH300004
5 mg
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264472
Locations
| United States, Tennessee | |
| Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Adherex Technologies, Inc.
Investigators
| Principal Investigator: | Howard Burris, III, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Clinical Study Manager, Adherex Technoloogies |
| ClinicalTrials.gov Identifier: | NCT00264472 History of Changes |
| Other Study ID Numbers: | Adherex Protocol # AHX-03-104 |
| Study First Received: | December 12, 2005 |
| Last Updated: | December 12, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Adherex Technologies, Inc.:
|
Cancer Tumors Neoplasms |
Anticarcinogenic Agents Antineoplastic Agents Dihydrouracil Dehydrogenase (NADP) |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Hepatocellular Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Liver Neoplasms Digestive System Neoplasms Digestive System Diseases Liver Diseases Antineoplastic Agents Fluorouracil Dihydrouracil Dehydrogenase (NADP) Anticarcinogenic Agents 5-ethynyluracil Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 22, 2013