A Phase II Evaluation of Elesclomol and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Sponsor: GOG, IND# 110072)
OBJECTIVES:
Primary
- To estimate the antitumor activity of elesclomol sodium and paclitaxel, in terms of the
frequency of objective tumor responses, in patients with persistent or recurrent
platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- To determine the nature and degree of toxicity of elesclomol sodium and paclitaxel in
these patients.
Secondary
- To estimate the progression-free survival and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive elesclomol sodium IV over 1 hour and paclitaxel IV over 1 hour on days 1,
8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
No
Bradley J. Monk, MD
Study Chair
Chao Family Comprehensive Cancer Center
United States: Federal Government
CDR0000641202
NCT00888615
December 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Gynecologic Oncology | Hinsdale, Illinois 60521 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Northwest Hospital and Medical Center | Seattle, Washington 98133 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
St. Mary Regional Cancer Center at St. Mary Medical Center | Walla Walla, Washington 99362 |
Lyndon B. Johnson General Hospital | Houston, Texas 77026-1967 |
St. Vincent Oncology Center | Indianapolis, Indiana 46260 |