Overview

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