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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Bevacizumab
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>XELIRI/Avastin | Drug: Capecitabine<br>* Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles<br>* Other names: Xeloda;Drug: Bevacizumab<br>* Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles<br>* Other names: Avastin;Drug: Irinotecan<br>* Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles<br>* Other names: CPT-11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Progression |  | 1 year | 
| Toxicity profile |  | Toxicity assessment on each chemotherapy | 
| Quality of life |  | Assessment every two cycles | 
| Symptoms improvement |  | Assessment every two cycles | 
| Overall Survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Bevacizumab, XELIRI