A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

Status:

COMPLETED

A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

Lead Sponsor:

Adherex Technologies, Inc.

Conditions:

Neoplasms

Eligibility:

All Genders

19+ years

Phase:

PHASE1

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 examin...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00264446

Last Update

August 6 2007

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