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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celator Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00361842
First received: August 7, 2006
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Celator Pharmaceuticals:

Primary Outcome Measures:
  • Response rate will be assessed using RECIST criteria. [ Time Frame: Q2months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse experiences and changes in laboratory values [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
    CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361842

Locations
United States, California
California Cancer Center
Greenbrae, California, United States, 94904
United States, District of Columbia
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center
Washington DC, District of Columbia, United States, 20057
United States, Florida
NW Oncology & Hematology Associates
Coral Springs, Florida, United States, 33065
Broward Oncology Associates
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
St. Joseph's/Candler Health System Inc.
Savannah, Georgia, United States, 31405
United States, North Carolina
Presbyterian Hospital
Charlotte,, North Carolina, United States, 28204
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oklahoma
Cancer Care Oklahoma
Oklahoma City, Oklahoma, United States
Cancer Care Oklahoma
Tulsa, Oklahoma, United States
United States, South Carolina
South Carolina Oncology Association
Columbia, South Carolina, United States, 29210
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Celator Pharmaceuticals
Investigators
Principal Investigator: Gerald Batist, MD Sir Mortimer B. Davis - Jewish General Hospital
Principal Investigator: John Marshall, MD Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Study Director: Arthur Louie, MD Celator Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Celator Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00361842     History of Changes
Other Study ID Numbers: Protocol CLTR0105-201
Study First Received: August 7, 2006
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celator Pharmaceuticals:
Colorectal cancer
Colorectal carcinoma
Colonic cancer
Rectal cancer

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Floxuridine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014