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
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, Bevacizumab, XELIRI
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
Sites / Locations
- University Hospital of Crete, Dep of Medical Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
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
No
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
1
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
No
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
Learn more about this trial
Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment
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