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Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum


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

Thank you

Trial Information

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with
evidence of metastases

- At least one measurable metastatic lesion (as per RECIST criteria)

- Life expectancy of > 12 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Prior chemotherapy for metastatic disease

- Clinically significant cardiovascular disease

- Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose
for gastrointestinal ulceration

- Participation in an investigational trial in the previous 3 months

- Pregnant or lactating women

- History of thrombotic or haemorrhagic disorders

- Evidence of bleeding diathesis or coagulopathy

- Uncontrolled hypertension

- Known hypersensitivity to Avastin and any of its excipients, or any of the
chemotherapies

- Evidence of any disease or disorder that contraindicates the use of an
investigational drug or puts the patient at high risk for treatment-related
complications

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 3.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Study ID:

ML28411

NCT ID:

NCT01830647

Start Date:

April 2013

Completion Date:

September 2016

Related Keywords:

  • Colorectal Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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