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

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

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

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 molar ratio. CPX-1 was developed as a means of delivering and
preserving a fixed 1:1 molar ratio of the two drugs. This ratio was found in vitro and in
vivo models of cancer to have synergistic anti-cancer activity and preservation and delivery
of this ratio is important because other ratios of these two drugs have been found to be
antagonistic or only additive. Both floxuridine and irinotecan HCl are active
chemotherapeutic agents, each approved for clinical use in the United States and Canada for
colorectal cancer. Current practice routinely administers 5- fluorouracil with irinotecan
in combination regimens in first or second line treatment without the means of preserving
the synergistic ratio.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate will be assessed using RECIST criteria.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Gerald Batist, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir Mortimer B. Davis - Jewish General Hospital


United States: Food and Drug Administration

Study ID:

Protocol CLTR0105-201



Start Date:

July 2006

Completion Date:

December 2008

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal cancer
  • Colorectal carcinoma
  • Colonic cancer
  • Rectal cancer
  • Neoplasms
  • Colorectal Neoplasms



California Cancer Center Fresno, California  93720
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Broward Oncology Associates Ft. Lauderdale, Florida  33308
Gabrail Cancer Center Canton, Ohio  44718
Sarah Cannon Research Institute Nashville, Tennessee  37203
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center Washington DC, District of Columbia  20057
NW Oncology & Hematology Associates Coral Springs, Florida  33065
St. Joseph's/Candler Health System Inc. Savannah, Georgia  31405
Cancer Care Oklahoma Oklahoma City, Oklahoma  
South Carolina Oncology Association Columbia, South Carolina  29210