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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Hospital of Crete.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00717990
First received: July 16, 2008
Last updated: March 13, 2012
Last verified: July 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University Hospital of Crete:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: April 2008
Estimated Study Completion Date: December 2012
Estimated 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

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717990

Contacts
Contact: Dora Hatzidaki +302810392570 dorachat@med@uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr

Locations
Greece
University Hospital of Crete, Dep of Medical Oncology Recruiting
Heraklion, Greece
Contact: Dora Hatzidaki    +302810392570    dorachat@med.uoc.gr   
Contact: Eva Maragkoudaki    +302810392857    dorachat@med.uoc.gr   
Sub-Investigator: Nikos Vardakis, MD         
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: V.Georgoulias, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00717990     History of Changes
Other Study ID Numbers: CT/05.35
Study First Received: July 16, 2008
Last Updated: March 13, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:
Colorectal cancer
Bevacizumab
XELIRI

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Capecitabine
Fluorouracil
Irinotecan
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 24, 2014