Spots Global Cancer Trial Database for Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
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Trial Identification
Brief Title: Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
Official Title: A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # 101018) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT00569673
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Detailed Description: OBJECTIVES: Primary * To estimate the antitumor activity of docetaxel plus trabectedin in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer primarily through the frequency of objective tumor responses. * To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients. Secondary * To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin. OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts recover. Treatment repeats every 3 weeks 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center, Mentor, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Carilion Gynecologic Oncology Associates, Roanoke, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Bradley J. Monk, MD
Affiliation: Chao Family Comprehensive Cancer Center
Role: STUDY_CHAIR
Name: Kristine M. Zanotti, MD
Affiliation: MacDonald Physicians, Incorporated at University MacDonald Womens Hospital
Role:
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