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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Bevacizumab; Camptothecin; Capecitabine; Fluorouracil; Irinotecan; Leucovorin

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