Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

NCT01120158 | Terminated Phase 2

• 1 other identifier: CT/08.31
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Elderly; Chemotherapy; Anti-angiogenesis therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Objective responses confirmed by CT or MRI every 3 months

Secondary Outcomes (3)

• Toxicity profile

  Toxicity assessment every month

• Time to Tumor Progression

  1-year

• Overall Survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

Paclitaxel/Bevacizumab

Drug: Bevacizumab; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

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.

Also known as: Avastin

1

Paclitaxel DRUG

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.

Also known as: Taxoprol, Paxene, Taxol, Ovapac

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (11)

University General Hospital of Alexandroupolis

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

University Hospital of Crete

Heraklion, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Diabalkaniko" hospital, Thessaloniki

Thessaloniki, Greece

Location

: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Paclitaxel

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

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete

  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: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 10, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

GR (11)