A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Colorectal Cancer Clinical Trial

Official title:

An Expanded Access Program of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582970
• Other study ID #: ML18436
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2015
• Last updated: December 1, 2015
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: Taiwan
• Study type: Interventional

Clinical Trial Summary

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously untreated metastatic colon or rectal cancer

• Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

Exclusion Criteria:

• Prior chemotherapy for metastatic colon or rectal cancer

• Planned radiotherapy for underlying disease

• Central nervous system metastases

• 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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Neoplasm Metastasis

Intervention

Drug:
• 5-Fluorouracil
Intravenous 5-fluorouracil based chemotherapy will be administered for approximately 10 months. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
• Bevacizumab
Bevacizumab will be administered IV 5 mg/kg every 2 weeks for approximately 10 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to approximately 3 years	No
Secondary	Duration of survival		Up to approximately 3 years	No
Secondary	Time to disease progression		Up to approximately 3 years	No
Secondary	Direct medical cost for cancer related medical care utilization		Up to approximately 3 years	No