An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

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

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Podgorica, , Montenegro

Site Status

Countries

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Montenegro

Other Identifiers

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ML28411

Identifier Type: -

Identifier Source: org_study_id