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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Heraklion, Greece
    • University Hospital of Crete, Dep of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital of Crete

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Colorectal cancer; Bevacizumab; XELIRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Bevacizumab; Irinotecan
• Other Study ID Numbers: CT/05.35