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

NCT00361842 | Completed Phase 2 Results

• 1 other identifier: Protocol CLTR0105-201
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 13

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. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.

Conditions

Colorectal Neoplasms

Keywords

Colorectal cancer; Colorectal carcinoma; Colonic cancer; Rectal cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0

  Disease response was assessed using RECIST 1.0. Measurable disease and target lesions were determined prior to study entry. Changes in the largest diameter (unidimensional measurement) of the sum of the target tumor lesions were used in the RECIST criteria. Best response on study was classified as follows. Complete Response (CR), disappearance of all clinical and radiological evidence of tumor. Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters. Stable Disease (SD), steady state of disease. Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD. Progressive Disease (PD) at least a 20% increase in the sum of the longest diameters of measured lesions taking as references the smallest sum of longest diameters recorded since the treatment started. Appearance of new lesions also constituted progressive disease.

  From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Progression-free Survival (PFS) Per RECIST Version 1.0

  Progression-free survival (PFS) was defined as the time from the first dose to the documentation of progressive disease (PD), death, or lost to follow-up at last assessment visit.

  Every 8 weeks

Secondary Outcomes (1)

• Duration of Response (DoR) Per RECIST Version 1.0

  Every 8 weeks

Study Arms (1)

Irinotecan

EXPERIMENTAL

Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection

Interventions

CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection DRUG

CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.

Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (13)

California Cancer Center

Greenbrae, California, 94904, United States

Location

Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

NW Oncology & Hematology Associates

Coral Springs, Florida, 33065, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308, United States

Location

St. Joseph's/Candler Health System Inc.

Savannah, Georgia, 31405, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Cancer Care Oklahoma

Oklahoma City, Oklahoma, United States

Location

Cancer Care Oklahoma

Tulsa, Oklahoma, United States

Location

South Carolina Oncology Association

Columbia, South Carolina, 29210, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Liposomes

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Results Point of Contact

• Title: Director, Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@JazzPharma.com

2158709177

Study Officials

• Gerald Batist, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• John Marshall, MD

  Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

  PRINCIPAL INVESTIGATOR

• Arthur Louie, MD

  Jazz Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 9, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-07

Locations

US (11); CA (2)