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An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer


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

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Trial Information

An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer


Inclusion Criteria:



- Patients with metastatic colon or rectal cancer, progressing or relapsing after
first-line treatment;

- Women of childbearing potential must use adequate contraception up to at least 6
months after the last dose of bevacizumab.

Exclusion Criteria:

- Patients with metastatic colon or rectal cancer scheduled for a first-line systemic
treatment;

- Untreated brain metastases, spinal cord compression or primary brain tumours;

- Pregnant or lactating women;

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study start;

- Treatment with any investigational drug, or participation in another investigational
study, within 30 days prior to enrollment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy: Overall control of disease (defined as overall response rate plus stable disease, by RECIST criteria)

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ML18559

NCT ID:

NCT01181609

Start Date:

June 2005

Completion Date:

May 2010

Related Keywords:

  • Colorectal Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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