A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623805
• Other study ID #: ML21440
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2008
• Last updated: July 16, 2014
• Start date: March 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, = 18 years of age.

• Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.

• At least 1 measurable lesion.

• Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

Exclusion Criteria:

• Previous treatment with Avastin.

• Previous systemic treatment for advanced or metastatic disease.

• clinically significant cardiovascular disease.

• Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroidal anti-inflammatory drugs.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
• Capecitabine
Capecitabine was supplied as film-coated tablets.
• Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.	Baseline to the end of the study (up to 4 years, 2 months)	No
Secondary	Overall Survival	Overall survival was defined as the time from the first administration of study drug to death.	Baseline to the end of the study (up to 4 years, 2 months)	No
Secondary	Percentage of Participants With a Complete Response or a Partial Response	A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.	Baseline to the end of the study (up to 4 years, 2 months)	No
Secondary	Time Until a Complete Response or a Partial Response	Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.	Baseline to Month 13	No
Secondary	Duration of Response	Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.	Baseline to the end of the study (up to 4 years, 2 months)	No
Secondary	Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery		Baseline to the end of the study (up to 4 years, 2 months)	No
Secondary	Percentage of Participants With a R0 Resection	An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.	Baseline to the end of the study (up to 4 years, 2 months)	No