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

This study has been terminated.
(Poor Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717990
First Posted: July 18, 2008
Last Update Posted: October 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vassilis Georgoulias, MD, University Hospital of Crete
  Purpose
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.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Capecitabine Drug: Bevacizumab Drug: Irinotecan Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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.

Resource links provided by NLM:


Further study details as provided by Vassilis Georgoulias, MD, University Hospital of Crete:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures:
  • Time To Progression [ Time Frame: 1 year ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy ]
  • Quality of life [ Time Frame: Assessment every two cycles ]
  • Symptoms improvement [ Time Frame: Assessment every two cycles ]
  • Overall Survival [ Time Frame: 1 year ]

Enrollment: 15
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
XELIRI/Avastin
Drug: Capecitabine
Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Other Name: Xeloda
Drug: Bevacizumab
Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
Other Name: Avastin
Drug: Irinotecan
Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other Names:
  • Campto
  • CPT-11

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717990


Locations
Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Greece
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

Responsible Party: Vassilis Georgoulias, MD, MD, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00717990     History of Changes
Other Study ID Numbers: CT/05.35
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Vassilis Georgoulias, MD, University Hospital of Crete:
Colorectal cancer
Bevacizumab
XELIRI

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Capecitabine
Camptothecin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors


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