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

NCT ID: NCT00717990

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-12-31

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

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

XELIRI/Avastin

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles

Bevacizumab

Intervention Type: DRUG

Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles

Irinotecan

Intervention Type: DRUG

Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Interventions

Capecitabine

Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles

Intervention Type: DRUG

Bevacizumab

Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles

Intervention Type: DRUG

Irinotecan

Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Xeloda; Avastin; Campto; CPT-11

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Vassilis Georgoulias, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vassilis Georgoulias, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

University Hospital of Crete, Dep of Medical Oncology

Heraklion, , Greece

Countries

Greece

Other Identifiers

CT/05.35

Identifier Type: -

Identifier Source: org_study_id