A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and
doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
- Determine the complete and partial response rates of patients treated with this
regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Phase I:
- Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and
doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues
every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease
progression. Patients who respond to treatment after 2 or more courses may stop
protocol therapy to undergo peripheral blood stem cell transplantation.
Cohorts of 3-6 patients receive escalating doses of vinorelbine, gemcitabine, and
doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to
receive treatment with gemcitabine, vinorelbine, and doxorubicin HCl liposome at the
recommended phase II dose.
Phase II:
- Patients are assigned to 1 of 2 treatment groups.
- Group 1: Patients who have not undergone prior transplantation receive
vinorelbine, gemcitabine, and doxorubicin HCl liposome as in phase I.
- Group 2: Patients who have undergone prior transplantation receive lower doses of
vinorelbine, gemcitabine, and doxorubicin HCl liposome as in group 1.
Patients are followed every 6 months for 2 years and then annually for 6 years.
PROJECTED ACCRUAL: Approximately 3-100 patients (3-42 for phase I and 20-58 for phase II [29
per group]) will be accrued for this study within 3 years.
Interventional
Primary Purpose: Treatment
Nancy L. Bartlett, MD
Study Chair
Washington University Siteman Cancer Center
United States: Federal Government
CDR0000068042
NCT00006029
July 2000
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Saint Anthony Medical Center | Rockford, Illinois 61108 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Cooper University Hospital | Camden, New Jersey 08103 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Weill Medical College of Cornell University | New York, New York 10021 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
NorthEast Oncology Associates | Concord, North Carolina 28025 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Ministry Medical Group - Northern Region | Rhinelander, Wisconsin 54501 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |