Colorectal CancerPhase 2NCT00681876
Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer
A Phase 2 study testing Irinotecan, Avastin and Erbitux in people with Colorectal Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
Trial summary
This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Irinotecan, Avastin and Erbitux
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesGreece
- Study dates
- Apr 2008to Feb 2010
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced or metastatic colorectal cancer.
- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- ECOG performance status ≤ 2
- Age 18 - 72 years
- Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
- Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
- Patients must be able to understand the nature of this study
- Written informed consent
Who cannot join
- History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
- History of myocardial infarction or stroke within 6 months.
- Clinically significant peripheral vascular disease.
- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
- Presence of central nervous system or brain mets.
- Evidence of bleeding diathesis or coagulopathy.
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- Patients with known hypersensitive reaction to cetuximab
- Blood pressure > 150/100 mmHg.
- Pregnant or lactating woman.
- Life expectancy < 3 months.
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
- Metastatic infiltration of the liver >50%.
- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
- Active infection requiring antibiotics on Day 1.
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- Psychiatric illness or social situation that would preclude study compliance.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
401 Military Hospital of Athens
Athens
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
Air Forces Military Hospital of Athens
Athens
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
State General Hospital of Larissa
Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin
This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.
Read the detailed description
Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN
- Conditions
- Colorectal Cancer
- Being tested
- Irinotecan, Avastin, Erbitux
- Keywords
- Metastatic colorectal cancer, Second line, Irinotecan, Erbitux (Cetuximab), Avastin (Bevacizumab)
- 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 CPT-11, Campto
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
AvastinDrug
Also called Bevacizumab
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
ErbituxDrug
Also called Cetuximab
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Irinotecan+Avastin+Erbitux Receives: Drug: Irinotecan; Drug: Avastin; Drug: Erbitux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression
Measured: 1 year
Secondary outcomes (3)
Objective Response Rate
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile
Measured: Toxicity assessment on each chemotherapy cycle
Quality of life, Symptoms improvement
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- John Souglakos, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681876
- Sponsor's protocol ID
- CT/05.32
- Status last verified
- Feb 2013
- First submitted
- 19 May 2008
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin
- ClinicalTrials.gov ID
- NCT00681876
- Acronym / sponsor ID
- CT/05.32
- Conditions
- Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Second line, Irinotecan, Erbitux (Cetuximab), Avastin (Bevacizumab)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor accrual
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 May 2008 (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.
This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.
Detailed description
Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irinotecan, Drug: Avastin, Drug: ErbituxIrinotecan+Avastin+Erbitux |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed locally advanced or metastatic colorectal cancer.
- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- ECOG performance status ≤ 2
- Age 18 - 72 years
- Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
Key exclusion criteria (16 listed)
- History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
- History of myocardial infarction or stroke within 6 months.
- Clinically significant peripheral vascular disease.
- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
- Presence of central nervous system or brain mets.
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: CPT-11, CamptoIrinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression | Drug | 1 |
| AvastinAlso: BevacizumabAvastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression | Drug | 1 |
| ErbituxAlso: CetuximabErbitux (IV)500 mg/m2 on day 1 every two weeks until progression | Drug | 1 |
Primary outcome
Time To Progression
Time frame: 1 year
3 secondary outcomes
Objective Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life, Symptoms improvement
Time frame: Assessment every two cycles
Results and safety
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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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.
John Souglakos, MD principal investigator
University Hospital of Crete
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Avastin and Erbitux in people with Colorectal Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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 was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
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?
Time To Progression (time frame: 1 year). 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 13 Feb 2013.