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Spots Global Cancer Trial Database for Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

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Trial Identification

Brief Title: Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

Official Title: A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY

Study ID: NCT00002819

Conditions

Ovarian Cancer

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.

Detailed Description: OBJECTIVES: I. Compare progression-free and overall survival of patients with drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare selected health-related aspects of quality of life in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and disease state at reassessment laparotomy. Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4, and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5 assessments regardless of disease progression. PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States

University of California San Diego Cancer Center, La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

Sylvester Cancer Center, University of Miami, Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Lakeside), Chicago, Illinois, United States

University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Veterans Affairs Medical Center - Togus, Togus, Maine, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

New England Medical Center Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York, United States

Mount Sinai Medical Center, NY, New York, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States

Veterans Affairs Medical Center - Nashville, Nashville, Tennessee, United States

Vanderbilt Cancer Center, Nashville, Tennessee, United States

Vermont Cancer Center, Burlington, Vermont, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States

Contact Details

Name: William P. McGuire, MD

Affiliation: Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Role: STUDY_CHAIR

Name: Kenneth B. Miller, MD

Affiliation: Tufts Medical Center Cancer Center

Role: STUDY_CHAIR

Name: Patrick J. Stiff, MD

Affiliation: Loyola University

Role: STUDY_CHAIR

Name: Stephen L. Graziano, MD

Affiliation: State University of New York - Upstate Medical University

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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