Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

NCT ID: NCT00754351

Last Updated: 2012-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-02-29

Brief Summary

This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.

Detailed Description

Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in > 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Bevacizumab-\>Docetaxel-\>Gemcitabine

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression

Docetaxel

Intervention Type: DRUG

Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Gemcitabine

Intervention Type: DRUG

Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Interventions

Bevacizumab

Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression

Intervention Type: DRUG

Docetaxel

Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Intervention Type: DRUG

Gemcitabine

Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Avastin; Taxotere; Gemzar

Eligibility Criteria

Inclusion Criteria

• Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
• No HER2 overexpression or gene amplification
• At least one previous chemotherapy regimen for metastatic breast cancer
• Age ≥18 years
• Performance status (WHO) 0-2
• Life expectancy of at least 12 weeks
• Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
• Performance status (WHO) 0-2
• Adequate liver function (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) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
• Written informed consent

Exclusion Criteria

• Pregnant or lactating women
• Progressive brain metastases according to clinical or radiological criteria
• Brain metastases without prior radiation therapy
• Radiation therapy within the previous 4 weeks
• Previous radiation therapy to the only measurable lesion
• Proteinuria ≥ 500 mgr of protein daily
• Uncontrolled hypertension
• Documented hemorrhagic diathesis or coagulation disorder
• Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
• Thrombotic event within the previous 6 months
• Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
• Major surgical procedure within the previous 4 weeks
• Presence of nonhealing wound or fracture
• Peripheral neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
• Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
• Uncontrolled infection
• Any serious, uncontrolled comorbidity on the investigator's judgment
• Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
• Serious psychiatric illness

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Vassilis Georgoulias, MD

Prof. D. Mavroudis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitris Mavrudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

Countries

Greece

Other Identifiers

CT/08.01

Identifier Type: -

Identifier Source: org_study_id