Colorectal NeoplasmsPhase 2NCT00361842
Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
A Phase 2 study testing CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection in people with Colorectal Neoplasms, run by Jazz Pharmaceuticals at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Presbyterian Hospital
Charlotte, North Carolina, 28204
South Carolina Oncology Association
Columbia, South Carolina, 29210
NW Oncology & Hematology Associates
Coral Springs, Florida, 33065
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
California Cancer Center
Greenbrae, California, 94904
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Cancer Care Oklahoma
Oklahoma City, Oklahoma
St. Joseph's/Candler Health System Inc.
Savannah, Georgia, 31405
Cancer Care Oklahoma
Tulsa, Oklahoma
Lombardi Comprehensive Cancer Research Institute, Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T1E2
About this study
Official title: Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
- Keywords
- Colorectal cancer, Colorectal carcinoma, Colonic cancer, Rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-1 (Irinotecan HCl:Floxuridine) Liposome InjectionDrug
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan | Experimental | Not described Receives: Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every 8 weeks
Secondary outcomes (1)
Duration of Response (DoR) Per RECIST Version 1.0
The duration of overall response was measured from the time that measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall complete response was measured from the time measurement criteria were first met for complete response until the first date that recurrent disease was objectively documented.
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald Batist, MD, Principal investigator, Sir Mortimer B. Davis - Jewish General HospitalJohn Marshall, MD, Principal investigator, Lombardi Comprehensive Cancer Center, Georgetown University Medical CenterArthur Louie, MD, Study director, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361842
- Sponsor's protocol ID
- Protocol CLTR0105-201
- Status last verified
- Jul 2021
- First submitted
- 7 Aug 2006
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label, Phase 2 Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00361842
- Acronym / sponsor ID
- Protocol CLTR0105-201
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal cancer, Colorectal carcinoma, Colonic cancer, Rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Aug 2006 (estimated)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan | Experimental | Drug: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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):
- Prior therapy (Group 2, irinotecan refractory):
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPX-1 (Irinotecan HCl:Floxuridine) Liposome InjectionCPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. | Drug | Irinotecan |
Primary outcome
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
Time frame: 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
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.
Progression-free Survival (PFS) Per RECIST Version 1.0
Time frame: Every 8 weeks
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.
1 secondary outcome
Duration of Response (DoR) Per RECIST Version 1.0
Time frame: Every 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Batist, MD principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
John Marshall, MD principal investigator
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Arthur Louie, MD study director
Jazz Pharmaceuticals
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection in people with Colorectal Neoplasms, run by Jazz Pharmaceuticals at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.