Celator Reports Positive Results From Phase II Colorectal Cancer Trial
Posted on: Wednesday, 4 June 2008, 12:00 CDT
Celator Pharmaceuticals has reported positive results from its CPX-1 Phase II clinical trial in patients with advanced colorectal cancer. CPX-1 is a liposomal formulation of irinotecan and floxuridine, based on the company's proprietary CombiPlex technology.
The multi-center, open-label, Phase II study had two arms, irinotecan-naive (IRI-naive) and irinotecan-refractory (IRI-refractory). IRI-naive patients had less than or equal to two prior regimens; one adjuvant/neoadjuvant and no more than one regimen for advanced disease.
IRI-refractory patients had disease progression within six months of prior irinotecan-containing treatment and started CPX-1 treatment within 12 months of disease progression following irinotecan. Patients received 210 units/m2 of CPX-1 every two weeks.
Approximately 26 patients were treated in the IRI-naive arm. The overall response rate (ORR) was 8% and the disease control rate (patients who achieved a response or stable disease) was 65%. Median progression- free survival (PFS) was 3.9 months. Six patients had a >6 month PFS. These data compare favorably to results published from other studies with irinotecan or an irinotecan-based regimen in this patient population which report an approximate 4% response rate and median PFS of 2.5 months.
Approximately 33 patients were treated in the IRI-refractory arm. The disease control rate was 45%; no patient achieved an objective response. The median PFS was 2.3 months. Three patients had a >6 month PFS. The disease control and median PFS are similar to results achieved in this patient population for approved agents (panitumumab or cetuximab monotherapy).
Arthur Louie, chief medical officer of Celator, said: "This study shows that well established drugs with proven activity may offer greater clinical benefit when a synergistic ratio is identified and the individual drugs are locked into a drug delivery vehicle able to deliver and maintain the desired ratio in patients."
Source: Datamonitor
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