Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma

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.