Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer

Abstract/full free pdf: published March 11, 2010


Patients:
Women who were at least 18 years old with recurrent, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer; measurable disease as defined
by RECIST; had received at least 1 but fewer than 4 prior platinum-containing chemotherapy regimens; at least 1 prior paclitaxel-containing regimen; and considered platinum refractory or resistant disease according to the standard GOG criteria (had progressed during or had persistent disease after completion of platinum-based therapy or had a platinum-free interval of < 6 months) were enrolled. There were no additional limits to lines of therapy.


Procedures:
Canfosfamide was administered as a 30-minute constant rate intravenous (IV) infusion
on day 1 of each 4-week cycle at 960 mg/m2 followed by PLD at 50 mg/m2 IV at an initial
rate of infusion of 1 mg/min.  If no acute infusion reactions occurred, subsequent doses of
PLD were administered over 1 hour.  Treatment cycles were repeated every 4 weeks until
tumor progression.  Cycles of therapy could be postponed up to 4 weeks due to toxicity;
longer toxicity delays led to study treatment discontinuation.  Premedications and the use of
growth factor and transfusion support were permitted.





RESULTS:
Patient Demographics and Ovarian Cancer Disease Characteristic - see article/76% serous

.....In our phase 2 study, the response rate of 25.6% and DSR of 76.9% supports that the
combination regimen is more active in the treatment of platinum resistant ovarian cancer than expected from either agent alone.  These results are likely due to the distinct mechanisms of action for each drug, as well as non-overlapping toxicities with prior carboplatin-paclitaxel therapy and canfosfamide's non-cross resistance with platinum and taxanes.....In summary, the phase 3 results are consistent with the canfosfamide plus PLD
regimen phase 2 results presented in this paper.  Further study is planned with canfosfamide
in combination with PLD, an active, well tolerated regimen in patients with platinum
refractory and primary platinum resistant ovarian cancer.