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Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101)


Phase 1
19 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101)


Inclusion Criteria:



- Signed written informed consent

- > or = 19 years of age

- Patients with histologically confirmed:

- primary or metastatic (known or suspected) colorectal carcinoma requiring
planned surgical resection with hepatic biopsy and systemic chemotherapy , or

- primary or metastatic neoplastic disease within the liver from any origin
requiring planned surgical resection and systemic chemotherapy

- Adequate performance status and organ function, as evidenced by hematological and
biochemical blood testing

Exclusion Criteria:

- Lack of known or suspected metastatic disease in the liver

- Known DPD deficiency

- Severe infection

- Inability to take oral medication

- The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose

- Stroke, major surgery, or other major tissue injury within 30 days before study entry

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Martin Heslin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

Adherex Protocol # AHX-03-101

NCT ID:

NCT00264446

Start Date:

Completion Date:

Related Keywords:

  • Neoplasms
  • Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;
  • Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

UAB - Division of SurgeryBirmingham, Alabama  35294-3300