A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver
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ClinicalTrials.gov Identifier: NCT00001576 |
Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Neoplasm Liver Neoplasm Neoplasm Metastasis | Drug: Melphalan Drug: Floxuridine Drug: Leucovorin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 28 participants |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver |
Study Start Date : | July 1997 |
Study Completion Date : | March 2002 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. Limited resectable extrahepatic disease is acceptable.
Patients must not have been previously treated with intrahepatic artery infusional therapy using FUDR.
Patients mush have had no chemotherapy, radiotherapy or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.
Patients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment.
Patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a PT and PTT that are within 1-2 seconds of the upper normal limit.
Patients must not have biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies.
Patients must not have a history of congestive heart failure with an LVEF less than 40%.
Patients must not have COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age.
Patients must be 18 years of age or older.
Patients must have a platelet count greater than 100,000 a Hct greater than 27.0, a white blood count greater than 3000/micro liters, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.
Patients must not be pregnant or nursing.
Patients must not be taking immunosuppressive drugs or on chronic anticoagulation.
Patients must not have an active infection.
Patients must not have severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids.
Patients must not have HIV disease.
Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001576
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001576 |
Other Study ID Numbers: |
970111 97-C-0111 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | March 2002 |
Regional Therapy Organ Perfusion Metastases Hyperthermia |
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Liver Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Liver Diseases Leucovorin Melphalan Floxuridine Antidotes Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |