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.

Exclusion Criteria:

* Prior treatment with irinotecan or an irinotecan-containing regimen (Group 1 only)
* Intolerant of an irinotecan-containing regimen (Group 2 only)
* Without documented evidence of irinotecan-refractoriness (Group 2 only)
* Chemotherapy or investigational anticancer therapeutic drugs in the four weeks prior to study entry.
* Hypersensitivity to irinotecan, floxuridine or liposomal products.
* History of Wilson's disease or other copper-related disorder.
* Clinically significant cardiac disease (New York Heart Association Class III or IV).
* Severe debilitating pulmonary disease.
* Active infection requiring continuing intravenous antibiotic treatment; recent infections must have resolved at least 5 days
* Severe or active enteropathy or recurrent onset of diarrhea, defined as an excess of 2 to 3 stools above the normal daily rate within the past four weeks.
* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or lactating women. Continued use of a drug or other product known to induce or inhibit CYP3A4. ---Patients must discontinue these products for at least 2 week prior to enrollment.