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

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00717990
• Other study ID #: CT/05.35
• Status: Terminated
• Phase: Phase 2
• First received: July 16, 2008
• Last updated: October 6, 2015
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Capecitabine
Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
• Bevacizumab
Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
• Irinotecan
Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		up to 6 months	No
Secondary	Time To Progression		1 year	No
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy	Yes
Secondary	Quality of life		Assessment every two cycles	No
Secondary	Symptoms improvement		Assessment every two cycles	No
Secondary	Overall Survival		1 year	No