Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment - Full Text View

Sponsored by:	University Hospital of Crete
Information provided by:	University Hospital of Crete
ClinicalTrials.gov Identifier:	NCT00717990

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Capecitabine Bevacizumab

U.S. FDA Resources

Further study details as provided by University Hospital of Crete:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ 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:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

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

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:	University Hospital of Crete ( V.Georgoulias )
Study ID Numbers:	CT/05.35
Study First Received:	July 16, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00717990 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:

Colorectal cancer
Bevacizumab
XELIRI

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Bevacizumab
Intestinal Diseases

Angiogenesis Inhibitors
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Irinotecan
Colonic Diseases
Bevacizumab
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

Capecitabine
Digestive System Neoplasms
Growth Substances
Enzyme Inhibitors
Intestinal Diseases
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009