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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celator Pharmaceuticals; Jazz Pharmaceuticals
• Treatments: Camptothecin; Floxuridine; Irinotecan

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.