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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients

NCT01183494

Metastatic Colorectal Cancer

COMPLETED PHASE1

Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer

NCT02138617

Colon Cancer

COMPLETED PHASE2

A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

NCT00615056

Colorectal Neoplasms

COMPLETED PHASE2

OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

NCT00940303

Colorectal Cancer

COMPLETED PHASE2

Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified Chemotherapy

NCT01126866

Colorectal Carcinoma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

FOLFIRI/Avastin

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

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

5-Fluorouracil

Intervention Type 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

Leucovorin

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

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

2

XELIRI/Avastin

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles

Irinotecan

Intervention Type DRUG

Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Irinotecan

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

Intervention Type 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

Intervention Type DRUG

Leucovorin

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Bevacizumab

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

Intervention Type DRUG

Bevacizumab

Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles

Intervention Type DRUG

Irinotecan

Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CPT-11 5-FU LV Xeloda Avastin Avastin CPT-11

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No