Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

NCT00469443 | Completed Phase 3

• 1 other identifier: CT/05.16
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 8

Brief Summary

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

Conditions

Colorectal Cancer

Keywords

Metastatic colorectal cancer; Irinotecan; Capecitabine; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Time To Progression

  1 year

Secondary Outcomes (5)

• Objective Response Rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

• Overall Survival

  Probability of 1-year survival (%)

• Toxicity profile

  Toxicity assessment on each chemotherapy cycle

• Quality of life

  Assessment every two cycles

• Symptoms improvement

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

FOLFIRI/Avastin

Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Bevacizumab

2

EXPERIMENTAL

XELIRI/Avastin

Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan

Interventions

Irinotecan DRUG

Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles

Also known as: CPT-11

1

5-Fluorouracil DRUG

5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles

Also known as: 5-FU

1

Leucovorin DRUG

Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles

Also known as: LV

1

Capecitabine DRUG

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

Also known as: Xeloda

2

Bevacizumab DRUG

Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles

Also known as: Avastin

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
• ECOG performance status ≤ 2
• Age 18 - 72 years
• Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
• Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
• Patients must be able to understand the nature of this study
• Written informed consent

You may not qualify if:

• Previous 1st line chemotherapy
• Adjuvant chemotherapy with Irinotecan regimen with relapse \< 6 months after the completion
• Active infection
• History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow
• Patients with unstable CNS metastases
• Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women
• Patients \> 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (8)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Related Publications (1)

• Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12.

  PMID: 22240792 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Fluorouracil; Leucovorin; Capecitabine; Bevacizumab

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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; 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

Study Officials

• John Souglakos, MD

  johnsougl@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: December 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

GR (8)