A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral
etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma.
II. Determine the nature and degree of toxicity of this therapy in these patients. III.
Evaluate the response rate of patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl
liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by
oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or
complete response, treatment repeats every 4 weeks for 1 year in the absence of disease
progression or unacceptable toxicity. For patients with stable disease, treatment repeats
every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3
patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for
more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl
liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at
which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then
until death.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.
Interventional
Primary Purpose: Treatment
Peter G. Rose, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000066375
NCT00003380
May 1998
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
Women's Cancer Center | Palo Alto, California 94304 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
Brookview Research, Inc. | Winston-Salem, North Carolina 27103 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Evanston | Evanston, Illinois 60201 |
North Shore University Hospital | Manhasset, New York 11030 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Medicine Branch | Bethesda, Maryland 20892 |
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Radiation Oncology Branch | Bethesda, Maryland 20892 |