- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120158
Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer
February 22, 2017 updated by: Hellenic Oncology Research Group
Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer
This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer.
Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Elderly individuals make up a large part of the breast cancer population.
Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer.
However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts.
Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations.
Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandroupolis, Greece
- University General Hospital of Alexandroupolis
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Athens, Greece
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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Athens, Greece
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
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Athens, Greece
- "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
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Athens, Greece
- 401 Military Hospital of Athens
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Athens, Greece
- Air Forces Military Hospital of Athens
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Athens, Greece
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Heraklion, Greece
- University Hospital of Crete
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Larissa, Greece
- State General Hospital of Larissa, Dep of Medical Oncology
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Thessaloniki, Greece
- "Diabalkaniko" hospital, Thessaloniki
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Thessaloniki, Greece
- : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic breast adenocarcinoma
- No previous therapy (other than hormonal therapy) for metastatic disease is accepted
- Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
- Performance status (WHO) 0-2
- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
- adequate renal function (serum creatinine <1.5 times the upper normal limit)
- bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- No radiation of measurable disease (except brain metastases)
- No progressive brain metastases according to clinical or radiological criteria
- No brain metastases without prior radiation therapy
- Written informed consent
Exclusion Criteria:
- Active infection
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- History of stroke
- Anticoagulation therapy (except of low dose aspirin <325mg)
- Other invasive malignancy except non-melanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Paclitaxel/Bevacizumab
|
Bevacizumab (IV) 10 mg/kg on day 1 and day 15.
Treatment repeats every 28 days.
Therapy will continue until maximum response, disease progression or unacceptable toxicity.
Other Names:
Paclitaxel (IV) 120 mg/m2,on day 1 and day 15.
Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Response Rate
Time Frame: Objective responses confirmed by CT or MRI every 3 months
|
Objective responses confirmed by CT or MRI every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Tumor Progression
Time Frame: 1-year
|
1-year
|
Overall Survival
Time Frame: 1 year
|
1 year
|
Toxicity profile
Time Frame: Toxicity assessment every month
|
Toxicity assessment every month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
January 1, 2017
Study Completion (ACTUAL)
January 1, 2017
Study Registration Dates
First Submitted
May 5, 2010
First Submitted That Met QC Criteria
May 7, 2010
First Posted (ESTIMATE)
May 10, 2010
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- CT/08.31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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