Clinical Research
Protocols
Clinical Research Protocols for Liver Tumors
Compiled by Margeret Gross-King, RN, MS, OCN
Clinical Research Manager, H. Lee Moffitt Cancer Center & Research Institute
AECMT940025, NCIT940025D
Phase II Study of 5FU/IFNA/HU in Advanced Cancer of the Pancreas, Stomach, or
Biliary System and Hepatocellular Carcinoma (Summary last modified 01/95).
Chairperson: Scott Wadler, Montefiore Medical Center, Bronx, NY. Lead organization:
Albert Einstein Cancer Research Center. Acceptable age: 18 and over.
AG337008, NCIV950633
Phase II Study of AG337 (a Thymidylate Synthase Inhibitor) as a 5Day Continuous
Infusion for Primary Hepatocellular Carcinoma (Summary last modified 08/95).
Chairperson: Neil J. Clendeninn, Agouron Pharmaceuticals, Inc., La Jolla, Calif. Lead
organization: Agouron Pharmaceuticals, Inc. Acceptable age range: 18 and over.
CINJM1364, NCIV940482
Phase II Pilot Study of UltrasoundGuided Hepatic Cryosurgery Plus Alternating
Intrahepatic Artery FUdR and 5FU for Liver Cancer (Summary last modified 11/94).
Chairperson: Thanjavur Subramanian Ravikumar, Cancer Institute of New Jersey, Robert
Wood Johnson Medical School, New Brunswick, NJ. Lead organization: Cancer Institute of New
Jersey. Acceptable age range: 18 and over.
LACUSC0C942, NCIT950081H
Phase I Pharmacodynamic Study Randomized for Sequence of Administration of HU and 5FU
for Advanced Solid Tumors (Summary last modified 08/96).
Chairperson: Colin Paul Spears, University of Southern California School of Medicine,
Los Angeles, Calif. Lead organization: University of Southern California/Norris
Comprehensive Cancer Center. Acceptable age range: 18 and over.
NCI92C0054N, NCIT910170N, NCIMB281
Phase I Study of Oral Administration of CAI for Refractory Cancers (Summary last
modified 02/96).
Chairperson: Elsie Kohn, Clinical Pharmacology Branch, DCS, National Cancer Institute,
Bethesda, Md. Lead organization: Division of Clinical Sciences, NCI. Acceptable age range:
18 and over.
NCI93C0105J, NCIT940129N
Phase I/II Study of Hyperthermic Isolated Hepatic Perfusion With TNF/LPAM for Primary
or Metastatic Hepatic Cancer (Summary last modified 08/96).
Chairperson: H. Richard Alexander, Surgery Branch, DCS, National Cancer Institute,
Bethesda, Md. Lead organization: Division of Clinical Sciences, NCI. Acceptable age range:
18 and over.
RPMIDS8924, NCIV890190
Phase I Study of CF/FUdR for Hepatomas and Cholangiocarcinomas (Summary last modified
06/95).
Chairperson: Harold O. Douglass, Jr., Roswell Park Cancer Institute, Buffalo, NY. Lead
organization: Roswell Park Cancer Institute. Acceptable age range: 18 and over.
SCCC92083, NCIV930289
Phase II Study of Chemoembolization With Hepatic Artery Infusion of CDDP/TSPA in
Lipiodol in Patients With Primary Hepatic Tumors or Liver Metastases (Summary last
modified 06/95).
Chairperson: Lynn G. Feun, Sylvester Comprehensive Cancer Center, University of Miami,
Miami, Fla. Lead organization: Sylvester Comprehensive Cancer Center, University of Miami.
Acceptable age range: 18 and over.
SLUMC7228, NCIV930316
Phase II Study of Hepatic Arterial Infusion With FLAPDM (FUdR/CF/DOX/CDDP/DM)
Followed by Surgical Resection or Orthotopic Liver Transplantation and Adjuvant Systemic
FLAPDM or VCDM (VBL/CYSP/DM) in Hepatocellular Carcinoma (Summary last modified
02/94).
Chairperson: Frank R. Dunphy, St. Louis University Health Sciences Center, St. Louis,
Mo. Lead organization: St. Louis University Health Sciences Center. Acceptable age range:
no greater than 65.
STLMCBRM93001, NCIV930250
Phase II Study of TIL/IL2/CTX in Patients With Refractory Solid Tumors (Summary last
modified 09/94).
Chairperson: John P. Hanson, Jr, St. Luke's Medical Center, Milwaukee, Wis. Lead
organization: St. Luke's Medical Center. Acceptable age range: over 16.
UCHSC93092, NCIV950657
Phase II Study of Cryosurgical Destruction of Unresectable Primary or Metastatic Liver
Tumors (Summary last modified 08/95).
Chairperson: Greg V. Stiegmann, University of Colorado Cancer Center, Denver, Colo.
Lead organization: University of Colorado Cancer Center. Acceptable age range: over 21.
UWPLCV930223, NCIV930223
Phase I/II Study of Liver Transplant With Pre, Peri, and Postoperative Chemotherapy
for Stage II Liver Cancer: Neoadjuvant Systemic DOX/5FU Plus Hepatic Artery
Chemoembolization With CDDP/PVA, Perioperative DOX, and Adjuvant CDDP/DOX/5FU (Summary
last modified 05/95).
Chairperson: Charles R. Thomas, Jr, University of Washington Medical Center, Seattle,
Wash. Lead organization: University of Washington Medical Center. Acceptable age range: no
age specified.
VX-96-710-003, NCI-V96-0931
Phase II Randomized Study of Doxorubicin With vs Without VX-710 (a Multidrug Resistance
Inhibitor) for Inoperable Primary Hepatocellular Carcinoma (Summary last modified 09/96).
Chairperson: Simon J. Hatch, Vertex Pharmaceuticals, Cambridge, Mass. Lead
organization: Vertex Pharmaceuticals. Acceptable age range: 18 and over.
YALEHIC8188, NCIV950734, YALE01328
Phase II Study of Hemodynamically Isolated Hepatic Infusion of Doxorubicin in
Unresectable Liver Tumor (Summary last modified 01/96).
Chairperson: WenJen Poo, Yale Comprehensive Cancer Center, New Haven, Conn. Lead
organization: Yale Comprehensive Cancer Center. Acceptable age range: 18 and over.
CANNCICCO7, NCIV940464
Phase III Randomized Study of Immediate vs Delayed 5FU/LCF for Colorectal Cancer
After Potentially Curative Resection of Liver or Lung Metastases (Summary last modified
09/95).
Chairperson: Anthony L. A. Fields, University of Alberta, W. W. Cross Cancer Institute,
Edmonton, Alberta, Canada. Lead organization: NCICClinical Trials Group. Acceptable age
range: any age.
CLB9481
Phase III Randomized Study of an Hepatic Arterial Infusion of FUdR/CF/DM vs Systemic
5FU/CF for Hepatic Metastases Secondary to Colorectal Cancer (Summary last modified
06/96).
Chairperson: Nancy E. Kemeny, Memorial SloanKettering Cancer Center, New York, NY.
Lead organization: Cancer and Leukemia Group B. Acceptable age range: 18 and over.
EST9288, INT0103
Phase III Comparison of Intrahepatic Artery FUdR and Systemic 5FU vs No Chemotherapy
Following Resection of 13 Hepatic Metastases in Patients With Colorectal Cancer (Summary
last modified 02/96).
Chairperson: Mary Margaret Kemeny, North Shore University Hospital, Manhasset, NY. Lead
organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 and over.
MRCCR05, EU95032
Phase III Randomized Study of Intravenous vs Intrahepatic Arterial Infusion of 5FU/CF
for Colorectal Cancer Metastatic to the Liver (Summary last modified 02/96).
Chairperson: David J. Kerr, Queen Elizabeth Hospital, CRC Institute of Cancer Studies,
Birmingham, England, UK. Lead organization: United Kingdom Medical Research Council.
Acceptable age range: any age.
MSKCC91137A6, NCIV920023
Phase III Randomized Study of Adjuvant Hepatic Arterial FUdR Plus Systemic 5FU/CF vs
Systemic 5FU/CF Alone in Resected Hepatic Metastases From Colorectal Cancer (Summary
last modified 12/95).
Chairperson: Nancy E. Kemeny, Memorial SloanKettering Cancer Center, New York, NY.
Lead organization: Memorial SloanKettering Cancer Center. Acceptable age range: 18 and
over.
NCCTG924652
Phase II Study of Multiple Metastasectomy Combined With Systemic 5FU/CF and Hepatic
Artery Infusion of FUdR in Patients With Colorectal Carcinoma Metastatic to the Liver
(Summary last modified 04/96).
Chairperson: John S. Bolton, Ochsner Cancer Institute, New Orleans, La. Lead
organization: North Central Cancer Treatment Group. Acceptable age range: 20 and over.
Legend for Abbreviations:
| AECM |
= Albert Einstein College of Medicine |
| AG |
= Agouron Pharmaceuticals, Inc |
| CAN-NCIC |
= National Cancer Institute of Canada |
| CINJ |
= Cancer Institute of New Jersey
|
| CLB |
= Cancer and Leukemia Group B
|
| EST |
= Eastern Cooperative Oncology Group
|
| LAC-USC |
= University of Southern California
|
| MRC |
= United Kingdom Medical Research Council
|
| MSKCC |
= Memorial Sloan-Kettering Cancer Center
|
| NCCTG |
= North Central Cancer Treatment Group
|
| NCI |
= National Cancer Institute
|
| RPMI |
= Roswell Park Memorial Institute
|
| SCCC |
= Sylvester Comprehensive Cancer Center
|
| SLUMC |
= St. Louis University Medical Center
|
| UCHSC |
= University of Colorado Health Sciences Center
|
| UW-PLC |
= University of Washington
|
| VX |
= Vertex Pharmaceuticals
|
| YALE |
= Yale University |
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Journal Volume 3 Number 5