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

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ClinicalTrials.gov Identifier: NCT00203411
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Translational Oncology Research International

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine (Xeloda) Drug: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Capecitabine (Xeloda)
1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period

Drug: Bevacizumab
7.5 mg/kg IV will be administered every 3 weeks




Primary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: 12 months ]
    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

  2. Number of Subjects Requiring Dose Modifications [ Time Frame: 3 months ]
    Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.


Secondary Outcome Measures :
  1. Response Rates [ Time Frame: every 21 days up to 12 months ]
    Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

  2. Quality of Life of Patients [ Time Frame: Baseline, Cycle 2, and End of Study ]

    Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) - a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.

    The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.

    The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 'Best imaginable health state' and 100 'Worst imaginable health state'.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203411


Locations
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United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Pacific Shores Medical Group
Long Beach, California, United States, 90813
UCLA Medical Center
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91328
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Sponsors and Collaborators
Translational Oncology Research International
Genentech, Inc.
Investigators
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Study Chair: Arash Naeim, MD, PhD University of California, Los Angeles
Study Chair: Randy Hecht, MD University of California, Los Angeles

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Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00203411     History of Changes
Obsolete Identifiers: NCT00217685
Other Study ID Numbers: TORI GI-04
First Posted: September 20, 2005    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: March 2016

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action