Myocet Plus Endoxan for Older Patients With Breast Cancer

NCT ID: NCT01120171

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-05-31

Brief Summary

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

Detailed Description

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line 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

Cyclofosfamide/Liposomal-encapsulated doxorubicin

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

Therapy will continue until maximum response,or unacceptable toxicity.

Liposomal-encapsulated doxorubicin

Intervention Type: DRUG

Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.

Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

Therapy will continue until maximum response or unacceptable toxicity.

Interventions

Cyclophosphamide

Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

Therapy will continue until maximum response,or unacceptable toxicity.

Intervention Type: DRUG

Liposomal-encapsulated doxorubicin

Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.

Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

Therapy will continue until maximum response or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Endoxan; Myocet

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed metastatic breast adenocarcinoma
• No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
• 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)
• Adequate cardiac function (LVEF within normal limits)
• Adequate bone marrow function (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

Exclusion Criteria

• Active infection
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
• Other invasive malignancy except non-melanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women

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

Sponsors

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Mavrudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University General Hospital of Alexandroupolis

Alexandroupoli, , Greece

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

Athens, , Greece

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

Athens, , Greece

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

Athens, , Greece

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

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

University Hospital of Crete

Heraklion, , Greece

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, , Greece

"Diabalkaniko" hospital, Thessaloniki

Thessaloniki, , Greece

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

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/08.32

Identifier Type: -

Identifier Source: org_study_id