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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001576 |
Purpose
Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan. Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M2/day as a 2-week continuous infusion regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasm Liver Neoplasm Neoplasm Metastasis |
Drug: Melphalan Drug: Floxuridine Drug: Leucovorin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| 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 |
| Estimated Enrollment: | 28 |
| Study Start Date: | July 1997 |
| Estimated Study Completion Date: | March 2002 |
Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan. Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M(2)/day as a 2-week continuous infusion regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.
Eligibility| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
More Information
| Study ID Numbers: | 970111, 97-C-0111 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001576 History of Changes |
| Health Authority: | United States: Federal Government |
|
Regional Therapy Organ Perfusion Metastases Hyperthermia |
|
Antimetabolites Melphalan Liver Diseases Immunologic Factors Gastrointestinal Diseases Colonic Diseases Leucovorin Rectal Diseases Fever Liver Neoplasms Vitamins Neoplasm Metastasis Micronutrients |
Alkylating Agents Digestive System Neoplasms Vitamin B Complex Floxuridine Trace Elements Folinic Acid Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Antineoplastic Agents, Alkylating Colorectal Neoplasms |
|
Antimetabolites Melphalan Liver Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Leucovorin Rectal Diseases Liver Neoplasms Neoplastic Processes Neoplasms by Site |
Pathologic Processes Vitamins Therapeutic Uses Neoplasm Metastasis Micronutrients Alkylating Agents Vitamin B Complex Digestive System Neoplasms Floxuridine Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms |