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

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00469443
First received: May 3, 2007
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Capecitabine
Drug: Bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Probability of 1-year survival (%) ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ 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 ]

Estimated Enrollment: 330
Study Start Date: December 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FOLFIRI/Avastin
Drug: Irinotecan
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
Other Name: CPT-11
Drug: 5-Fluorouracil
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
Other Name: 5-FU
Drug: Leucovorin
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
Other Name: LV
Drug: Bevacizumab
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
Other Name: Avastin
Experimental: 2
XELIRI/Avastin
Drug: Capecitabine
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Other Name: Xeloda
Drug: Bevacizumab
Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
Other Name: Avastin
Drug: Irinotecan
Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other Name: CPT-11

Detailed Description:

There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.

  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
  • 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

Exclusion Criteria:

  • 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
  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: NCT00469443

Locations
Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: John Souglakos, MD johnsougl@gmail.com
  More Information

No publications provided by Hellenic Oncology Research Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J.Sougklakos, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00469443     History of Changes
Other Study ID Numbers: CT/05.16
Study First Received: May 3, 2007
Last Updated: August 18, 2010
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Metastatic colorectal cancer
Irinotecan
Capecitabine
Bevacizumab

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
Fluorouracil
Capecitabine
Irinotecan
Bevacizumab
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 21, 2014