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Journal of Oncology 3
Table 1: Current trials in ovarian/fallopian/peritoneal cancer.
Author N Prior lines Platinum S/R
/first line Regimen
∗∗
RR:CR + PR TTP/PFS median
BurgerRetal.[7]621-2 +/+ Single 21 % PFS 4.7mo
Cannistra et al. [8]442-3 +/+ Single 15.9% PFS 4.4 mo
Garcia et al. [9]7013+/+ Combo 24% TTP 7.2 mo
Wright et al. [10]23215
/+ Combo 35 % TTP 5.6 mo
Chura et al. [11]15515+/+ Combo 43 % PFS 3.9 mo
Nimeiri et al. [12]1313 +/+ Combo 15 % PFS 4.1 mo
Monk et al. [13]32210
/+ Single 16 % PFS 5.5 mo
Simpkins et al. [14]25212
/+ Combo 28 % TTP 9.0 mo
McGonigle et al. [15]1802
/+ Combo 22% PFS 3.8 mo
Azad et al. [17] 13 NR NR Combo 46% NR
Micha et al. [16] 20 0 First line Combo 80% NR
Campos/Penson et al. [18, 19] 58 0 First line Combo 75% PFS:11mo
Enrolled patients: platinum sensitive/resistant/first line.
∗∗
Single bevacizumab or combination therapy with cytotoxic or other biological agents.
NR: not reported.
ICON 6
Randomized
Carboplatin/paclitaxel + placebo followed
by placebo for 18 months
Carboplatin/paclitaxel + Cediranib followed
by placebo for 18 months
Carboplatin/paclitaxel + Cediranib followed
by Cediranib for 18 months
Figure 2: ICON-6.
day on a 4-week on 2-week oschedule. Noted in this study
was the development of pleural eusions during the 2-week
rest period. Of the seventeen patients that were studied 12%
of patients had a partial response, and 59% of patients had
disease stabilization. Currently the Harvard Cancer Center
Gynecological Group (NCT00768144) is conducting a phase
II trial using sunitinib in refractory ovarian caner patients.
The dose of sunitinib is held constant at 37.5 mg every day.
AMG 706 is an investigational inhibitor of vascular
endothelial growth factor receptors 1, 2, and 3, platelet-
derived growth factor receptor, and stem-cell factor receptor.
A Phase II Evaluation of AMG706 (NCT00574951) in the
Treatment of Persistent or Recurrent Epithelial Ovarian
Fallopian Tube or Primary Peritoneal Cancer is currently
active.
Matei et al. [26] reported on the activity of sorafenib in
patient with recurrent ovarian cancer. Sorafenib is a tyrosine
kinase inhibitor targeting raf and other receptor kinases
(VEGF-R, PDGF-R, Flt3, c-KIT). Patients received sorafenib
at 400 mg QD. Patients in this study have a 3% partial
response, and 20% of patients had stable disease for > than
6 months. Toxicities included rash, metabolic abnormalities,
gastrointestinal, cardiovascular, and pulmonary toxicity.
4. VEGF Trap (Aflibercept)
VEGF trap (Aflibercept) is fusion protein containing the
VEGF binding regions of both VEGFR-1 and 2 linked
through the Fc region of a human IgG1. Aflibercept binds
VEGF-A and neutralizes all VEGF-A isoforms plus placental
growth factor. This agent is currently being explored in plat-
inum resistant ovarian cancer. Columbo et al. [39]reported
the results of VEGF Trap in patients with symptomatic
malignant ascites. Aflibercept, 4 mg/kg, i.v. was administered
every 2 weeks, in patients with advanced ovarian cancer
and symptomatic ascites requiring frequent paracentesis. Pri-
mary endpoint was repeat paracentesis response rate (RPRR)
defined as at least a doubling of time to the first paracentesis
compared to a baseline average. Patients received 1–13 cycles
of aflibercept. The authors reported that the time to the
first paracentesis was 12–205 days. Eight out of ten evaluable
patients achieved a RPRR response as per protocol. Adverse
events included bowel obstruction, nausea, vomiting,
anorexia, edema, and 1 case of bowel perforation. Tew et al.
[40] reported the preliminary results of a randomized phase
II study in patients with recurrent platinum-resistant epithe-
lial ovarian cancer. VEGF Trap was (2 or 4 mg/kg) adminis-
tered intravenously every 2 weeks in patients with recurrent
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