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

Condition(s) targeted: Colorectal Cancer

Intervention: Irinotecan (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug); Capecitabine (Drug); Bevacizumab (Drug); Bevacizumab (Drug); Irinotecan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
John Souglakos, MD, Principal Investigator, Affiliation: johnsougl@gmail.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time To Progression

Secondary outcome:

Objective Response Rate

Overall Survival

Toxicity profile

Quality of life

Symptoms improvement

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.

Minimum age: 18 Years. Maximum age: 72 Years. Gender(s): Both.

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

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

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

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

401 Military Hospital of Athens, 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

Starting date: December 2006
Last updated: August 18, 2010