2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00600340
First received: January 14, 2008
Last updated: May 29, 2013
Last verified: December 2012
  Purpose

First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: Bevacizumab and Paclitaxel
Biological: Bevacizumab and Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of HER2-negative Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • To show non-inferiority of Arm B versus Arm A in terms of overall survival (OS). Overall survival is assessed from randomization until date of death. [ Time Frame: until date of death ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: April 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks

In both arms, treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent.

Biological: Bevacizumab and Paclitaxel
A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
Active Comparator: B

Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks

In both arms, treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent.

Biological: Bevacizumab and Capecitabine
B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks

Detailed Description:

Arm A:

Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks

Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks

Arm B:

Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks

Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks

In both arms treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent.

For patients who stop chemotherapy for any reason before PD (e.g. toxicity) the other treatment should be given as monotherapy until PD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Written informed consent
  • Age ≥18 years
  • Able to comply with the protocol
  • Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
  • ECOG performance status of 0-2
  • Life expectancy more than 12 weeks
  • Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization, if (neo)adjuvant Therapy was Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.
  • Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer If the last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, the last fraction of radiotherapy was administered ≥ 3 weeks prior to randomization.
  • Adequate left ventricular ejection function
  • Adequate hematological function
  • Adequate liver function
  • Adequate renal function
  • The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization

Exclusion Criteria:

  • Previous chemotherapy for metastatic or locally recurrent breast cancer
  • Concomitant hormonal therapy for locally recurrent or metastatic disease. Previous hormonal therapy must have been discontinued at least 3 weeks prior to randomization
  • Previous radiotherapy for the treatment of metastatic disease
  • Other primary tumors within the last 5 years, except for adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization.
  • Evidence of spinal cord compression or current evidence of CNS
  • History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures)
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment
  • Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization
  • Current or recent (within 10 days of first dose of bevacizumab) use of aspirin or clopidogrel
  • Chronic daily treatment with History or evidence of inherited bleeding diathesis or coagulopathy
  • Uncontrolled hypertension
  • Clinically significant cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
  • Non-healing wound, active peptic ulcer or bone fracture
  • History of abdominal fistula or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization
  • Active infection requiring i.v. antibiotics at randomization.
  • Pregnant or lactating females, Women of childbearing potential,not using contraception
  • Men who do not agree to use contraception
  • Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study
  • Clinically significant malabsorption syndrome or inability to take oral medication
  • Psychiatric disability
  • Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues. Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
  • Known DPD deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy
  • Known hypersensitivity to any of the study drugs or excipients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600340

  Show 55 Study Locations
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Christoph C Zielinski, MD Dep. of Internal Medicin I, Oncology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00600340     History of Changes
Other Study ID Numbers: CECOG/BC1.3.005
Study First Received: January 14, 2008
Last Updated: May 29, 2013
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Capecitabine
Bevacizumab
Fluorouracil
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014