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

NCT00717990 | Terminated Phase 2

• 1 other identifier: CT/05.35
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; Bevacizumab; XELIRI

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  up to 6 months

Secondary Outcomes (5)

• Time To Progression

  1 year

• Toxicity profile

  Toxicity assessment on each chemotherapy

• Quality of life

  Assessment every two cycles

• Symptoms improvement

  Assessment every two cycles

• Overall Survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

XELIRI/Avastin

Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

1

Bevacizumab DRUG

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

Also known as: Avastin

1

Irinotecan DRUG

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

Also known as: Campto, CPT-11

1

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (1)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

GR (1)