Clinical trial NCT00754351: Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer
Official title: Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: docetaxel
gemcitabine
bevacizumab
chemotherapy
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall response rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
measure: Toxicity profile
timeFrame: 21 days
measure: Overall Survival
timeFrame: 1 year
measure: Quality of life assessment
timeFrame: Assessment every two cycles
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Dimitris Mavrudis, MD
role: PRINCIPAL_INVESTIGATOR
References: