Spots Global Cancer Trial Database for Paclitaxel Albumin-Stabilized Nanoparticle Formulation 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: Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title: A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study ID: NCT00499252
Study Description
Brief Summary: This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Colorado Gynecologic Oncology Group, Aurora, Colorado, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Rush University Medical Center, Chicago, Illinois, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
University of Massachusetts Medical School, Worcester, Massachusetts, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore University Hospital, Manhasset, New York, United States
North Shore-LIJ Health System CCOP, Manhasset, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Cancer Care Associates-Midtown, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Lehigh Valley Hospital, Allentown, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
University of Texas Medical Branch at Galveston, Galveston, Texas, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Contact Details
Name: Robert Coleman
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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