This trial is active, not recruiting.

Condition colorectal cancer
Treatments capecitabine (xeloda), bevacizumab
Phase phase 2
Target VEGF
Sponsor Translational Oncology Research International
Collaborator Genentech
Start date March 2006
End date February 2012
Trial size 50 participants
Trial identifier NCT00203411, NCT00217685, TORI GI-04


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To determine the anti-tumor activity of bevacizumab plus capecitabine based on time to disease progression
time frame: 3 months
To evaluate the tolerability of bevacizumab plus capecitabine treatment in a patient population that is elderly or frail (poor performance)
time frame:

Secondary Outcomes

To determine response rates and duration of response
time frame:
To evaluate the effect of bevacizumab plus capecitabine treatment on the quality of life of patients
time frame: every 21 days
To evaluate cost-effectiveness
time frame:
To measure the rate of the functional decline
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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 - 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-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

Additional Information

Official title A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Translational Oncology Research International.