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

Phase 2

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan

• Registration Number: NCT00717990
• Lead Sponsor: University Hospital of Crete

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 selected the dosing schedule of the trials TREE 1 and 2 \[17\], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Irinotecan	XELIRI/Avastin
1	Capecitabine	XELIRI/Avastin
1	Bevacizumab	XELIRI/Avastin

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	Assessment every two cycles
Toxicity profile	Toxicity assessment on each chemotherapy
Symptoms improvement	Assessment every two cycles
Time To Progression	1 year
Overall Survival	1 year

Trial Locations

Locations (1)

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Greece