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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

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To determine the anti-tumor activity of bevacizumab plus capecitabine based on time to disease progression

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Arash Naeim, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms



Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
UCLA Medical Center Los Angeles, California  90095-7059
Virginia K. Crosson Cancer Center Fullerton, California  92835
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
Cancer Care Associates Medical Group, Inc. Torrance, California  90505
Central Hematology Oncology Medical Group, Inc. Alhambra, California  91801
Central Coast Medical Oncology Corporation Santa Maria, California  93454