Spots Global Cancer Trial Database for Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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Trial Identification
Brief Title: Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title: A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT00888615
Conditions
Study Description
Brief Summary: This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses. II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel. OUTLINE: Patients receive paclitaxel intravenously (IV) over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
John Muir Medical Center-Concord Campus, Concord, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
University of California San Diego, San Diego, California, United States
John Muir Medical Center-Walnut Creek, Walnut Creek, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
University of Connecticut, Farmington, Connecticut, United States
Hartford Hospital, Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Piedmont Hospital, Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
McFarland Clinic PC - Ames, Ames, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Woman's Hospital, Baton Rouge, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional, Burlington, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee, Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina, United States
Cone Heath Cancer Center at Mebane, Mebane, North Carolina, United States
Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina, United States
Annie Penn Memorial Hospital, Reidsville, North Carolina, United States
Novant Health Cancer Institute - Thomasville, Thomasville, North Carolina, United States
Novant Health Cancer Institute - Wilkesboro, Wilkesboro, North Carolina, United States
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
Winston-Salem Health Care, Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Summa Health System - Akron Campus, Akron, Ohio, United States
Cleveland Clinic Akron General, Akron, Ohio, United States
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States
Delaware Radiation Oncology, Delaware, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lancaster Radiation Oncology, Lancaster, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Newark Radiation Oncology, Newark, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Jefferson Abington Hospital, Abington, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Black Hills Obstetrics and Gynecology, Rapid City, South Dakota, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Wellmont Bristol Regional Medical Center, Bristol, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City, Johnson City, Tennessee, United States
Regional Cancer Center at Indian Path Community Hospital, Kingsport, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, United States
Lyndon Baines Johnson General Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
University of Vermont Medical Center, Burlington, Vermont, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Southwest VA Regional Cancer Center, Norton, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
University of Washington Medical Center - Northwest, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Contact Details
Name: Bradley J Monk
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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