Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Bevacizumab; Camptothecin; Cetuximab; Irinotecan

Criteria

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.