Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754351
• Other study ID #: CT/08.01
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2008
• Last updated: June 26, 2012
• Start date: September 2008
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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
• Docetaxel
Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
• Gemcitabine
Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		up to 6 months	No
Secondary	Progression Free Survival		1 year	No
Secondary	Toxicity profile		21 days	Yes
Secondary	Overall Survival		1 year	No
Secondary	Quality of life assessment		Assessment every two cycles	No