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

NCT00203411 | Completed Phase 2 Results DMC

• 1 other identifier: TORI GI-04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 12

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Time to Disease Progression

  Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date

  12 months

• Number of Subjects Requiring Dose Modifications

  Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.

  3 months

Secondary Outcomes (2)

• Response Rates

  every 21 days up to 12 months

• Quality of Life of Patients

  Baseline, Cycle 2, and End of Study

Study Arms (1)

Bevacizumab Plus Capecitabine

EXPERIMENTAL

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.

Drug: Capecitabine (Xeloda); Drug: Bevacizumab

Interventions

Capecitabine (Xeloda) DRUG

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

Bevacizumab Plus Capecitabine

Bevacizumab DRUG

7.5 mg/kg IV will be administered every 3 weeks

Bevacizumab Plus Capecitabine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Translational Oncology Research International: lead
• Genentech, Inc.: collaborator

Study Sites (12)

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

North Valley Hematology/Oncology Medical Group

Northridge, California, 91328, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Wilshire Oncology Medical Group, Inc.

Pomona, California, 91767, United States

Location

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, 90277, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Bevacizumab

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)

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

Limitations and Caveats

This was a small study with only 45 participants who received study treatment. With such a small sample size the study does not have the statistical power to make categorical assessments or statements.

Results Point of Contact

• Title: Dr. Arash Naeim
• Organization: Translational Research in Oncology

anaeim@mednet.ucla.edu

310 267-6810

Study Officials

• Arash Naeim, MD, PhD

  University of California, Los Angeles

  STUDY CHAIR

• Randy Hecht, MD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 6, 2017
• Results First Posted: February 6, 2017

Record last verified: 2016-03

Locations

US (12)