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 20, 2014
Last verified: May 2014
  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 2015
Estimated Primary Completion Date: November 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600340

  Hide Study Locations
Locations
Austria
LKH Leoben
Leoben, Austria, 8700
AKH Linz, Dep. of Oncology
Linz, Austria, 4020
Hospital Barmherzige Schwestern
Linz, Austria, 4010
Hospital Elisabethinen Linz
Linz, Austria, 4020
Univ. Klinik, Medicine III
Salzburg, Austria, 5020
2. Med. Abteilung - LKH-Steyr
Steyr, Austria, 4400
Hospital Hietzing
Vienna, Austria, 1130
General Hospital, Medical University of Vienna
Vienna, Austria, 1090
Bosnia and Herzegovina
Institute of Oncology Sarajevo
Sarajevo, Bosnia and Herzegovina
Bulgaria
Cancer Center Plovdiv
Plovdiv, Bulgaria, 4000
University Hospital "Queen Joanna"
Sofia, Bulgaria, 1527
Interdistrict Oncology Dispensary
Varna, Bulgaria
Croatia
Department for Oncology, GH Osijek
Osijek, Croatia, 31000
General Hospital Pula
Pula, Croatia, 52100
University Hospital Centre Rijeka
Rijeka, Croatia, 51000
University Hospital Rebro
Zagreb, Croatia
University Hospital for Tumors
Zagreb, Croatia
Czech Republic
Krajska nemocnice Liberec
Liberec, Czech Republic, 460 63
Institut onkologie a rehablilitace na Plesi
Nova Ves pod Plesi, Czech Republic
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 77520
Charles University Prague, Dep of Oncology
Prague, Czech Republic
Hungary
Semmelweis Univ. Radiology Clinic
Budapest, Hungary, 1082
National Institute of Oncology
Budapest, Hungary, 1122
Onkotherápiás Klinika,
Szeged, Hungary
Markusovszky Hospital
Szombathely, Hungary
Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah-Tikva, Israel
Tel Aviv Sourasky Medical Center, Div of Oncology
Tel Aviv, Israel
Sheba Medical Center
Tel Hashomer, Israel
Assuta Medical Center
Tel-Aviv, Israel
Latvia
Riga Eastern Hospital - the latvian Center of Oncology
Riga, Latvia, 1079
P. Stradins University Hospital
Riga, Latvia, 1020
Poland
Wojewodzkie Centrum Onkologii
Gdansk, Poland, 80-210
Medical University of Gdansk
Gdansk, Poland, 80-211
Klinika Onkologii CMuJ
Krakow, Poland, 31-501
Lodz Oncology Center
Lodz, Poland, 93-503
Centrum Medyczne Poradnia Onkologiczna
Rzeszow, Poland, 35-021
Wojewodzki Szpital Specialistyczny
Siedlce, Poland, 08-110
Szpital Wojewodzki im Sw. Lukasza
Tarnow, Poland, 33-100
Memorial Cancer Center and Institute
Warsaw, Poland, 02-781
Dolnoslaskie Centrum Onkologii
Wroclaw, Poland, 53-413
Romania
Emergency University Bucharest Hospital
Bucharest, Romania
Institutul Oncologic Bucuresti
Bukarest, Romania
Cancer Institute "I. Chiricuta"
Cluj-Napoca, Romania, 400015
University Hospital St. Spiridon Iasi
Iasi, Romania, 700111
Clinical County Hospital Sibiu
Sibiu, Romania, 550003
Oncomed-Oncology Practice
Timisoara, Romania, 300239
Serbia
Clinical Hospital Center " Bezanijska Kosa"
Belgrade, Serbia, 11080
Institute for Oncology and Radiology
Belgrade, Serbia, 11000
Clinic of Oncology
Nis, Serbia, 18000
Institute of Oncology
Sremska Kamenica, Serbia, 21204
Slovakia
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav
Bratislava, Slovakia, 81250
National Cancer Institute
Bratislava, Slovakia, 83310
Oncology Institute, Department of Radiotherapy and Onclogy
Kosice, Slovakia, 04191
POKO Porad, s.r.o
Poprad, Slovakia, 05801
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 20, 2014
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on September 16, 2014