Status:
TERMINATED
Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief 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 treatme...
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 IRINOTE...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00681876
Start Date
April 1 2008
End Date
February 1 2010
Last Update
February 13 2013
Active Locations (8)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
401 Military Hospital of Athens
Athens, Greece
3
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
Air Forces Military Hospital of Athens
Athens, Greece