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

Inclusion Criteria

• •Ability to understand and voluntarily sign an informed consent form
• •Age \> 18 years at the time of signing the informed consent form
• •Histological confirmation of advanced stage, primary or metastatic colorectal carcinoma
• •Prior therapy (Group 1, irinotecan naive):
• •* No more than one regimen for metastatic disease
• •* No more than two regimens overall; one for neoadjuvant/adjuvant and one for metastatic/advanced disease
• •Prior therapy (Group 2, irinotecan refractory):
• •* Disease progression on or within 3 months after prior irinotecan-containing regimen
• •* CPX-1 treatment must start within 6 months after documentation of disease progression on irinotecan (other therapies are permitted after irinotecan and before study entry)
• •Must have measurable disease as defined by RECIST
• •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• •Able to adhere to the study visit schedule and other protocol requirements
• •Life expectancy of at least 24 weeks
• •Laboratory values fulfilling the following:
• •* Absolute neutrophil count (ANC) \>1500 cells/mm3 (1.5 x 109/L)
• •* Platelet count \> 100,000/mm3 (100 x 109/L)
• •* Serum creatinine \<1.5 x upper limits of normal (ULN)
• •* Serum SGOT/AST and SGPT/ALT \<3 x upper limits of normal (ULN) (\<5 times ULN if caused by liver metastases)
• •* Serum total bilirubin \< 1.25 x upper limits of normal (\<2 times ULN if caused by liver metastases)
• •All men and women must agree to practice effective contraception during the study period and for three months afterward if not otherwise documented to be infertile.
• •Prior radiation therapy must be completed at least 4 weeks prior to enrollment and the patient recovered from any toxicity related to the radiation therapy.