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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


Phase 3
18 Years
72 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time To Progression

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John Souglakos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

johnsougl@gmail.com

Authority:

Greece: National Organization of Medicines

Study ID:

CT/05.16

NCT ID:

NCT00469443

Start Date:

December 2006

Completion Date:

February 2010

Related Keywords:

  • Colorectal Cancer
  • Metastatic colorectal cancer
  • Irinotecan
  • Capecitabine
  • Bevacizumab
  • Colorectal Neoplasms

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