Status:
TERMINATED
Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment
Lead Sponsor:
University Hospital of Crete
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief 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.
Detailed Description
The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was sel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00717990
Start Date
April 1 2008
End Date
December 1 2012
Last Update
October 7 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Greece