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

NCT00623805 | Completed Phase 3 Results

• 1 other identifier: ML21440
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Overall Survival

  Baseline to the end of the study (up to 4 years, 2 months)

• Percentage of Participants With a Complete Response or a Partial Response

  Baseline to the end of the study (up to 4 years, 2 months)

• Time Until a Complete Response or a Partial Response

  Baseline to Month 13

• Duration of Response

  Baseline to the end of the study (up to 4 years, 2 months)

• 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)

Study Arms (2)

Bevacizumab+capecitabine+oxaliplatin

ACTIVE COMPARATOR

Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.

Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin

Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C

EXPERIMENTAL

Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.

Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Bevacizumab DRUG

Bevacizumab was supplied as a solution in single-use vials.

Also known as: Avastin

Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C; Bevacizumab+capecitabine+oxaliplatin

Capecitabine DRUG

Capecitabine was supplied as film-coated tablets.

Also known as: Xeloda

Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C; Bevacizumab+capecitabine+oxaliplatin

Oxaliplatin DRUG

Oxaliplatin was supplied as a lyophilized powder in vials.

Also known as: Eloxatin

Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C; Bevacizumab+capecitabine+oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

Ankara, 06100, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06500, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06590, Turkey (Türkiye)

Location

Unknown Facility

Gaziantep, 27310, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34300, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34390, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34890, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35100, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35340, Turkey (Türkiye)

Location

Unknown Facility

S?hhiye, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 26, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 8, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-07

Locations

TU (10)