Colorectal Cancer (CRC)Phase 2NCT00851045
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Irinotecan, 5-Fluorouracil (bolus) and 5-Fluorouracil (infusional) in people with Colorectal Cancer (CRC), run by Bristol-Myers Squibb at 15 sites in 3 countries.
Trial summary
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Irinotecan, 5-Fluorouracil (bolus) and 5-Fluorouracil (infusional)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Oct 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ECOG Performance Status (PS) ≤1
- Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
- Measurable disease by RECIST guidelines
- Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
- Available paraffin embedded tumor tissue
- Willing to give a whole blood sample for the study of proteins and genetic polymorphisms
Who cannot join
- Less than 28 days elapsed since major surgery at time of randomization
- Known CNS metastases
- Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
- Uncontrolled hypertension
- Clinically significant cardiovascular disease
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
- Known HIV Positive
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States12 sites
Pharma Resource
East Providence, Rhode Island, 02915
Florida Cancer Specialists
Fort Myers, Florida, 33916
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, 92708
University Of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Midwest Center For Hematology/Oncology
Joliet, Illinois, 60432
Gurtler, Jayne
Metairie, Louisiana, 70006
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Compassionate Cancer Care Medical Group, Inc
Riverside, California, 92501
Sharp Memorial Hospital
San Diego, California, 92123
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
Cancer Center Of Kansas
Wichita, Kansas, 67214
Argentina2 sites
Local Institution
Bahía Blanca, Buenos Aires, 8000
Local Institution
Capital Federal, Buenos Aires, 1426
About this study
Official title: A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Irinotecan, 5-Fluorouracil (bolus), 5-Fluorouracil (infusional), Leucovorin calcium, CT-322
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Camptosar
Solution, IV, 180 mg/m2, Q14 days, Until PD
5-Fluorouracil (bolus)Drug
Solution, IV, 400 mg/m2, Q14 days, Until PD
5-Fluorouracil (infusional)Drug
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Solution, IV, 400 mg/m2, Q14 days, Until PD
CT-322Drug
Also called BMS-844203
Solution, IV, 2 mg/kg, Q7 days, Until PD
BevacizumabDrug
Also called Avastin
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Bevacizumab Placebo (saline solution)Drug
Also called Saline Solution
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322 Receives: Drug: Irinotecan; Drug: 5-Fluorouracil (bolus); Drug: 5-Fluorouracil (infusional); Drug: Leucovorin calcium; Drug: CT-322 |
| Arm 2 | Active comparator | Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution) Receives: Drug: Irinotecan; Drug: 5-Fluorouracil (bolus); Drug: 5-Fluorouracil (infusional); Drug: Leucovorin calcium; Drug: Bevacizumab; Drug: Bevacizumab Placebo (saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival based on tumor assessments (CT/MRI)
Measured: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Secondary outcomes (3)
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Measured: every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
Measured: every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851045
- Sponsor's protocol ID
- CA196-004
- Other IDs
- EUDRACT # 2008-006561-89
- Status last verified
- Sep 2015
- First submitted
- 23 Feb 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00851045
- Acronym / sponsor ID
- CA196-004
- Conditions
- Colorectal Cancer (CRC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
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 the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Irinotecan, Drug: 5-Fluorouracil (bolus), Drug: 5-Fluorouracil (infusional), Drug: Leucovorin calcium, Drug: CT-322Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322 |
| Arm 2 | Active comparator | Drug: Irinotecan, Drug: 5-Fluorouracil (bolus), Drug: 5-Fluorouracil (infusional), Drug: Leucovorin calcium, Drug: Bevacizumab, Drug: Bevacizumab Placebo (saline solution)Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG Performance Status (PS) ≤1
- Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
- Measurable disease by RECIST guidelines
- Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
- Available paraffin embedded tumor tissue
Key exclusion criteria (8 listed)
- Less than 28 days elapsed since major surgery at time of randomization
- Known CNS metastases
- Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
- Uncontrolled hypertension
- Clinically significant cardiovascular disease
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 |
|---|---|---|
| IrinotecanAlso: CamptosarSolution, IV, 180 mg/m2, Q14 days, Until PD | Drug | Arm 1, Arm 2 |
| 5-Fluorouracil (bolus)Solution, IV, 400 mg/m2, Q14 days, Until PD | Drug | Arm 1, Arm 2 |
| 5-Fluorouracil (infusional)Solution, IV, 2400 mg/m2, Q14 days, Until PD | Drug | Arm 1, Arm 2 |
| Leucovorin calciumSolution, IV, 400 mg/m2, Q14 days, Until PD | Drug | Arm 1, Arm 2 |
| CT-322Also: BMS-844203Solution, IV, 2 mg/kg, Q7 days, Until PD | Drug | Arm 1 |
| BevacizumabAlso: AvastinSolutions, IV, 5 mg/kg, Q14 days, Until PD | Drug | Arm 2 |
| Bevacizumab Placebo (saline solution)Also: Saline SolutionSolution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD | Drug | Arm 2 |
Primary outcome
Progression free survival based on tumor assessments (CT/MRI)
Time frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
3 secondary outcomes
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Time frame: every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
Time frame: every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
Time frame: weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, 5-Fluorouracil (bolus) and 5-Fluorouracil (infusional) in people with Colorectal Cancer (CRC), run by Bristol-Myers Squibb at 15 sites in 3 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 6 inclusion and 8 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Argentina, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival based on tumor assessments (CT/MRI) (time frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent). 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 12 Oct 2015.