Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer
This study is currently recruiting participants.
Verified September 2012 by Hellenic Oncology Research Group
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01120158
First received: May 5, 2010
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Bevacizumab Drug: Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity profile [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
- Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 46 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Paclitaxel/Bevacizumab
|
Drug: 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 Name: Avastin
Drug: Paclitaxel
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:
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120158
Contacts
| Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
| Contact: Eva Maragkoudaki | +302810392857 | dorachat@med.uoc.gr |
Locations
| Greece | |
| University General Hospital of Alexandroupolis | Recruiting |
| Alexandroupolis, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Stelios Kakolyris, MD | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Aris Polyzos, MD | |
| "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Nikos Ziras, MD | |
| "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106442666 secretary@horg.gr | |
| Principal Investigator: Nikos Malamos, MD | |
| 401 Military Hospital of Athens | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Charalampos Christophillakis, MD | |
| "IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Stelios Giassas, MD | |
| Air Forces Military Hospital of Athens | Recruiting |
| Athens, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Nikos Kentepozidis, MD | |
| University Hospital of Crete | Recruiting |
| Heraklion, Greece | |
| Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
| Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
| Sub-Investigator: Manolis Saloustros, MD | |
| State General Hospital of Larissa, Dep of Medical Oncology | Recruiting |
| Larissa, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Athanasios Athanasiadis, MD | |
| : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Recruiting |
| Thessaloniki, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Ioannis Boukovinas, MD | |
| "Diabalkaniko" hospital, Thessaloniki | Recruiting |
| Thessaloniki, Greece | |
| Contact: Spyros Georgiadis +302106448666 secretary@horg.gr | |
| Principal Investigator: Christos Emmanouilidis, MD | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
More Information
No publications provided
| Responsible Party: | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01120158 History of Changes |
| Other Study ID Numbers: | CT/08.31 |
| Study First Received: | May 5, 2010 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Breast cancer Elderly Chemotherapy Anti-angiogenesis therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013