Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
Intervention description: CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
Intervention MeSH terms: Irinotecan; Floxuridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal cancer; Colorectal carcinoma; Colonic cancer; Rectal cancer

Summary:

      The purpose of this study is to determine whether CPX-1 is effective in patients with
      advanced colorectal cancer who have already received chemotherapy that included the drug
      oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90
      minutes every two weeks.
    

Eligibility criteria:

        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.