Clinical Trials Logo
  1. Home
  2. Liver Neoplasm
  3. NCT00001576

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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00001576
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1
Start date July 1997
Completion date March 2002
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03775980 - CIRSE Emprint Microwave Ablation Registry
Completed NCT01114958 - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases Phase 1
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT04458259 - Study of PF-07265807 in Participants With Metastatic Solid Tumors. Phase 1
Completed NCT01218542 - Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc N/A
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Active, not recruiting NCT02395224 - A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Recruiting NCT01960829 - Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study Phase 2
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Recruiting NCT01564810 - Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer Phase 4
Completed NCT00375245 - Rapamycin With Grapefruit Juice for Advanced Malignancies Phase 1
Completed NCT00207116 - An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00207103 - MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT00172003 - Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis Phase 4