The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
829
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
Time frame: every 8 weeks
To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
Time frame: End of study
To determine the progression-free survival (PFS) of patients treated with patupilone
Time frame: end of study
To determine the time to disease progression (TTP) of patients treated with patupilone
Time frame: end of study
To determine overall best tumor response (CR, PR, SD, PD and Unknown)
Time frame: end of study
To investigate the safety and tolerability of patupilone
Time frame: end of study
To evaluate the pharmacokinetics (PK) of patupilone from all patients
Time frame: end of study
To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events
Time frame: end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alaska Cancer Research & Education Center
Anchorage, Alaska, United States
Northern Arizona Hematology & Oncology Associates
Flagstaff, Arizona, United States
Mayo Center for Women's Health
Scottsdale, Arizona, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Yanagihara, Ronald H.
Gilroy, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
University of California - San Diego/ Moores Cancer Center
La Jolla, California, United States
LAC & USC Women's & Children's Hospital
Los Angeles, California, United States
...and 139 more locations