Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

NCT ID: NCT00203411

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.

Detailed Description

The study will evaluate the tolerability, safety, and feasibility of combination bevacizumab and capecitabine in a small number of frail patients with metastatic colorectal cancer who have a compromised performance status. Preclinical studies suggest that the combination of chemotherapy and anti-angiogenic therapy offer an increased anti-tumor effect compared with either treatment alone.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab Plus Capecitabine

Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Group Type: EXPERIMENTAL

Capecitabine (Xeloda)

Intervention Type: DRUG

1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period

Bevacizumab

Intervention Type: DRUG

7.5 mg/kg IV will be administered every 3 weeks

Interventions

Capecitabine (Xeloda)

1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period

Intervention Type: DRUG

Bevacizumab

7.5 mg/kg IV will be administered every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis
• Stage IV disease, with at least one measurable lesion according to the RECIST criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 2
• No prior chemotherapy for metastatic colorectal cancer
• Prior adjuvant chemotherapy is permitted.
• At least 28 days since prior surgery
• If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months thereafter.
• Required laboratory values:

• Absolute neutrophil count > 1.5 x 10^9/L
• Hemoglobin > 9.0 g/dL
• Platelet count > 100 x 10^9/L
• Creatinine < 2.0 mg/dL
• Total bilirubin < 1.5 x upper limit of normal (ULN) (Patients with documented Gilbert's syndrome are eligible.)
• Alkaline phosphatase and AST/ALT within the following parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used:

• Alkaline phosphate and AST/ALT < or = ULN
• Alkaline phosphate > 1x but < or = 2.5x and AST/ALT < or = ULN
• Alkaline phosphate > 2.5x but < or = 5x and AST/ALT < or = ULN
• Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 1.5x
• Alkaline phosphate > 1x but < or = 2.5 x and AST/ALT > 1x but < or = 1.5x
• Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 2.5x

Exclusion Criteria

• Prior chemotherapy for metastatic colorectal cancer
• Prior treatment with an anti-angiogenic agent
• Concurrent therapy with any other non-protocol anti-cancer therapy
• Current or prior history of central nervous system or brain metastases
• Presence of neuropathy > grade 2 (NCI-Common Toxicity Criteria (CTC) version 3.0) at baseline
• Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease
• History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
• Clinically significant cardiovascular disease (e.g., blood pressure [BP] > 150/100, myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy
• Active infection requiring parenteral antimicrobials
• The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
• Inability to comply with the study protocol or follow-up procedures
• Pregnancy or lactation
• A history of a severe hypersensitivity reaction to bevacizumab, or capecitabine or other drugs formulated with polysorbate 80.
• Evidence of bleeding diathesis or coagulopathy.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to Day 0
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Unstable angina
• Urine protein creatinine ratio greater than or equal to 1.
• Therapeutic anticoagulation with oral anticoagulation medications, specifically coumarins

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Translational Oncology Research International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arash Naeim, MD, PhD

Role: STUDY_CHAIR

University of California, Los Angeles

Randy Hecht, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Virginia K. Crosson Cancer Center

Fullerton, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

UCLA Medical Center

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group

Northridge, California, United States

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Wilshire Oncology Medical Group, Inc.

Pomona, California, United States

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, United States

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

TORI GI-04

Identifier Type: -

Identifier Source: org_study_id

NCT00217685

Identifier Type: -

Identifier Source: nct_alias