A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # Pending) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective tumor response
No
Bradley J. Monk, MD
Study Chair
Chao Family Comprehensive Cancer Center
United States: Federal Government
CDR0000577866
NCT00569673
March 2008
Name | Location |
---|---|
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
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 |
Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |