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

Primary Purpose

Metastatic Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Capecitabine

Bevacizumab

Irinotecan

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, Bevacizumab, XELIRI

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Crete, Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

XELIRI/Avastin

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Time To Progression

Toxicity profile

Quality of life

Symptoms improvement

Overall Survival

Full Information

NCT ID

NCT00717990

First Posted

July 16, 2008

Last Updated

October 6, 2015

Sponsor

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00717990

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Poor Accrual

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Colorectal cancer, Bevacizumab, XELIRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

XELIRI/Avastin

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

Campto, CPT-11

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Time To Progression

Time Frame

1 year

Title

Toxicity profile

Time Frame

Toxicity assessment on each chemotherapy

Title

Quality of life

Time Frame

Assessment every two cycles

Title

Symptoms improvement

Time Frame

Assessment every two cycles

Title

Overall Survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vassilis Georgoulias, MD

Organizational Affiliation

University Hospital of Crete, Dep of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Crete, Dep of Medical Oncology

City

Heraklion

Country

Greece

12. IPD Sharing Statement

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

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