Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer

Disease response was assessed using RECIST 1.0. Measurable disease and target lesions were determined prior to study entry. Changes in the largest diameter (unidimensional measurement) of the sum of the target tumor lesions were used in the RECIST criteria. Best response on study was classified as follows. Complete Response (CR), disappearance of all clinical and radiological evidence of tumor. Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters. Stable Disease (SD), steady state of disease. Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD. Progressive Disease (PD) at least a 20% increase in the sum of the longest diameters of measured lesions taking as references the smallest sum of longest diameters recorded since the treatment started. Appearance of new lesions also constituted progressive disease.

Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Population: The response rate efficacy evaluable (RECIST) analysis set (n=21 in group 1 and n= 24 in group 2) included all enrolled participants who received at least 1 cycle of CPX-1 therapy (2 doses, Days 1 and 15) and had at least 1 measurable lesion assessed for response (either after every second cycle of treatment or earlier to document disease progression) after beginning treatment. Tumor response, based on the RECIST criteria, was assessed at baseline and every 8 weeks.

Progression-free survival (PFS) was defined as the time from the first dose to the documentation of progressive disease (PD), death, or lost to follow-up at last assessment visit.

Time frame: Every 8 weeks

Population: The efficacy evaluable analysis set or Full Analysis Set (25 patients in Group 1 and 32 participants in Group 2) included all enrolled participants who received at least 1 dose of CPX-1 therapy, and had at least one post-baseline PFS assessment.

The duration of overall response was measured from the time that measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall complete response was measured from the time measurement criteria were first met for complete response until the first date that recurrent disease was objectively documented.

Time frame: Every 8 weeks

Population: No participants had CR. Two participants in the naïve group had objective responses. One participant showed a PR on study day 57 that lasted for 5.8 months. One participant had a PR starting on study day 60 and persisting for 9.1 months at which time the data was censored. Due to the censored observation, the median DoR was not estimable (NE).