Bevacizumab and Capecitabine in Treatment of Elderly Patients With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by South Eastern European Research Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
South Eastern European Research Oncology Group
ClinicalTrials.gov Identifier:
NCT01195298
First received: August 26, 2010
Last updated: September 3, 2010
Last verified: August 2010
  Purpose

This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab administered as first-line treatment of previously untreated elderly patients, older than 70 years, with metastatic or locally recurrent breast cancer.


Condition Intervention Phase
Breast Cancer
Metastasis
Drug: Capecitabine and Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by South Eastern European Research Oncology Group:

Primary Outcome Measures:
  • Time to treatment progression [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
    followed until death


Secondary Outcome Measures:
  • overall response rate in patients with measurable disease at baseline [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
  • safety and tolerability [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
  • Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: May 2010
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine and Bevacizumab

    Drugs will be administered in 3-week cycles as follows:

    • Bevacizumab 15mg/kg via i.v. infusion on day 1
    • Capecitabine 1000 mg/m2 tablets twice-daily, on days 1 through 14.
    Other Names:
    • Bevacizumab (Avastin )
    • Capecitabine (Xeloda)
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the Protocol code: ML22373 Protocol SEEROG: version 1.2. Date: October 15, 2009 3 study requirements;
  • Age ≥70 years;
  • Pathologically confirmed and documented metastatic breast cancer or locally recurrent breast cancer not amenable to curative treatment. Complete radiology and tumor measurement workup must be completed within 4 weeks prior to first study treatment;
  • Measurable disease according to RECIST criteria;
  • HER2 negative disease;
  • No prior treatment for metastatic or locally recurrent disease;
  • Prior radiotherapy is allowed if delivered at least 2 weeks before enrolment in the study and for the relief of metastatic bone pain, and provided that no more than 30% of marrow bearing bone was irradiated and that target lesions were not included in the radiotherapy field;
  • Not suitable for aggressive chemotherapy regimen in the opinion of the investigator;
  • Performance status ECOG 0 - 2.

Exclusion Criteria:

  • Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less than 6 months prior to enrolment. The maximum cumulative dose received must not have exceeded 360 mg/m2 for doxorubicin or 720 mg/m2 for epirubicin. Prior anti-epidermal growth factor therapy is allowed;
  • Concurrent hormonal therapy; however previous hormonal therapy is allowed for adjuvant, locally recurrent, or metastatic breast cancer if completed within ≥1 months prior to enrolment;
  • History or clinical evidence of brain metastases. If there is any clinical suspicion of brain metastasis, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the brain must be conducted within 4 weeks prior to enrolment;
  • Other malignancy (including primary brain tumors) within the Protocol code: ML22373 Protocol SEEROG: version 1.2. Date: October 15, 2009 4 last 5 years, which could affect the diagnosis or assessment of breast cancer, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer;
  • Life expectancy < 12 weeks;
  • Any of the following abnormal values:

    • Inadequate bone marrow function: hemoglobin (Hb) < 8.0 g/dL, absolute neutrophil count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L;
    • Inadequate liver function: AST/SGOT or ALT/SGPT > 2.5 x upper limit of normal (ULN) or > 5 x ULN in patients with liver metastases), serum alkaline phosphatase > 2.5 ULN or > 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases or total bilirubin > 2 x ULN;
    • Moderate or severe renal impairment: creatinine clearance ≤50 mL/min (calculated according to the cockcroft and Gault formula; see Appendix 1), or serum creatinine > 1.5 x ULN;
  • Chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (> 75 mg / day);
  • Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids);
  • Requirement for concurrent use of the antiviral agents sorivudine or brivudine;
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or anticipation of the need for major surgery during the course of the study treatment;
  • Minor surgical procedures, within 24 hours prior to enrolment;
  • Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study.
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease, including:
  • Cerebrovascular accident/stroke (≤ 6 months prior to enrolment)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195298

Locations
Croatia
Clinical Hospital Split, Center of oncology Recruiting
Split, Croatia, 21000
Contact: Eduard Vrdoljak, PhD MD    00385-21-556-129    eduard.vrdoljak@st.htnet.hr   
Principal Investigator: Eduard Vrdoljak, PhD MD         
Sponsors and Collaborators
South Eastern European Research Oncology Group
Roche Pharma AG
Investigators
Principal Investigator: Eduard Vrdoljak, PhD MD Clinical Hospital Split, Center of oncology, Croatia
Principal Investigator: Damir Vrbanec, PhD MD Clinical Hospital Zagreb, Croatia
Principal Investigator: Katarina Petrakova, MD Masaryk Memorial Cancer Institue, Brno, Czech Republic
Principal Investigator: Gyorgy Bodoky, PhD MD FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET, ONKOLOGIAI OSZTALY, Budapest, Hungary
Principal Investigator: Tamas Pinter, MD Petz, Aladar Korhaz, Onkoradiologiai Osztaly, Gyor, Hungary
Principal Investigator: Vladimir Todorović, MD Oncology clinic, Clinical Center of Montenegro
Principal Investigator: Marek Wojtukiewicz, PhD MD Department of Oncology Medical University, Bialystok, Poland
Principal Investigator: Tadeusz Pienkowski, PhD MD Cancer Centre and Institute of Oncology Warsaw
Principal Investigator: Daniela Grecea, MD "Prof Dr. I Chiricuta" Cluj Napoca Oncology Institute - Breast Cancer Center, Cluj Napoca, Romania
  More Information

No publications provided

Responsible Party: Prof. dr. sc. Eduard Vrdoljak, Clinical Hospitl Split, Center of oncology
ClinicalTrials.gov Identifier: NCT01195298     History of Changes
Other Study ID Numbers: ML22373
Study First Received: August 26, 2010
Last Updated: September 3, 2010
Health Authority: Croatia: Ethics Committee

Keywords provided by South Eastern European Research Oncology Group:
metastatic breast cancer
elderly patients
chemoimmunotherapy
Triple negative metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Capecitabine
Fluorouracil
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014