Status:
COMPLETED
Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. The two drugs are present inside the liposome in a fixed 1:1 mola...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00361842
Start Date
July 1 2006
End Date
December 1 2008
Last Update
July 2 2021
Active Locations (13)
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1
California Cancer Center
Greenbrae, California, United States, 94904
2
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057
3
NW Oncology & Hematology Associates
Coral Springs, Florida, United States, 33065
4
Broward Oncology Associates
Fort Lauderdale, Florida, United States, 33308