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Clinical Trial 18803
Cancer Type: Gynecological Tumor
Interventions:Avastin (Bevacizumab); Bevacizumab; CA4P (fosbretabulin); Doxil (doxorubicin liposome); Placebo; Taxol (paclitaxel); doxorubicin liposome; paclitaxel
Study Type: Treatment
Phase of Study: Phase II/III
FOCUS: A Multicenter, Multinational, Double-Blind, 2-Arm, Randomized, Phase 2/3, Study of Physician's Choice Chemotherapy ([PCC] Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects with Platinum-Resistant, Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
The purpose of this study is to see if the addition of CA4P to the standard chemotherapy will increase the amount of time the participant's cancer stays in check, or in other words the amount of time their cancer is progression free. Other things that will be looked at are: how much, if any, their cancer shrinks; how well participant's feel during the study; their quality of life outlook; and, changes in cancer specific markers in their blood.
The main objective of the study is to demonstrate an improvement in PFS with standard PCC regimens (weekly paclitaxel or PLD) plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo. The secondary objectives of this study are: * Improvement in ORR (by RECIST and/or CA-125 criteria). * Evaluation of OS. * Assessment of the proportion of subjects who remain progression-free at 6, 9, and 12 months on the regimen of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo. * To evaluate the safety and tolerability, as measured by physical exams, vital signs, laboratory measures, ECOG PS and incidence of AEs using NCI CTCAE version 4.03, of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo.