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A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- adult patients >=18 years of age;

- colon or rectal cancer, with metastases;

- >=1 measurable lesion.

Exclusion Criteria:

- previous systemic treatment for advanced disease;

- radiotherapy to any site within 4 weeks before study;

- daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose
to gastrointestinal ulceration;

- co-existing malignancies or malignancies diagnosed within last 5 years (except basal
cell cancer or cervical cancer in situ).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression\n

Outcome Time Frame:

From the first day of treatment until the first observation of disease progression, or death due to any cause (up to 5 years)

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

ITALY: Agenzia Italiana del Farmaco

Study ID:

ML18524

NCT ID:

NCT01131078

Start Date:

June 2005

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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