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A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination


Inclusion Criteria:



- Adult patients, >=18 years of age

- Metastatic colorectal cancer and disease progression

- Previously treated with first-line chemotherapy plus Avastin

- ECOG <=2.

Exclusion Criteria:

- Diagnosis of progression of disease more than 3 months after last Avastin
administration

- First-line patients with progression-free survival in first-line of <3 months

- Patients receiving less than 3 consecutive months of Avastin in first-line therapy

- Past or current history (within the last 2 years prior to treatment start) of other
malignancies, except for curatively treated basal and squamous cell cancer of the
skin or in situ cancer of the cervix

- Clinically significant cardiovascular disease within 6 months prior to start of study
treatment

- Known CNS disease, except for treated CNS metastases as defined by protocol

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival (time from randomization to death of any cause)

Outcome Time Frame:

approximately 6.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Germany: Ethics Commission

Study ID:

ML18147

NCT ID:

NCT00700102

Start Date:

February 2006

Completion Date:

May 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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