Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.

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

Details

• Lead Sponsor: University Hospital of Crete
• Treatments: Bevacizumab; Camptothecin; Capecitabine; 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

• ECOG performance status ≤ 2

• Age 18 - 72 years

• Patients who progress after 1st line therapy with FOLFOX/AVASTIN

• Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit) renal (Creatinine ≤ 1.5 upper normal limit) 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

• Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1

• Presence of central nervous system or brain metastasis

• Evidence of bleeding diathesis or coagulopathy

• 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