Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

NCT00754351 | Completed Phase 2

• 1 other identifier: CT/08.01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

docetaxel; gemcitabine; bevacizumab; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  up to 6 months

Secondary Outcomes (4)

• Progression Free Survival

  1 year

• Toxicity profile

  21 days

• Overall Survival

  1 year

• Quality of life assessment

  Assessment every two cycles

Study Arms (1)

1

EXPERIMENTAL

Bevacizumab-\>Docetaxel-\>Gemcitabine

Drug: Bevacizumab; Drug: Docetaxel; Drug: Gemcitabine

Interventions

Bevacizumab 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

Also known as: Avastin

1

Docetaxel DRUG

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

Also known as: Taxotere

1

Gemcitabine DRUG

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

Also known as: Gemzar

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (2)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. D. Mavroudis

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

GR (2)