Colorectal Cancer Clinical Trial
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 72 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital of Alexandroupolis, Dep of Medical Oncology | Alexandroupolis | |
Greece | : "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Athens | |
Greece | 401 Military Hospital of Athens | Athens | |
Greece | Air Forces Military Hospital of Athens | Athens | |
Greece | IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Athens | |
Greece | State General Hospital of Larissa | Larissa | |
Greece | "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | Piraeus | |
Greece | "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Oncology Research Group | University Hospital of Crete |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time To Progression | 1 year | No | |
Secondary | Objective Response Rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | No | |
Secondary | Toxicity profile | Toxicity assessment on each chemotherapy cycle | Yes | |
Secondary | Quality of life, Symptoms improvement | Assessment every two cycles | No |
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