Myocet Plus Endoxan for Older Patients With Breast Cancer

NCT01120171 | Terminated Phase 2

• 1 other identifier: CT/08.32
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

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

Conditions

Breast Cancer

Keywords

Breast cancer; Elderly; Chemotherapy; Cardiotoxicity

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

Cyclofosfamide/Liposomal-encapsulated doxorubicin

Drug: Cyclophosphamide; Drug: Liposomal-encapsulated doxorubicin

Interventions

Cyclophosphamide 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.

Also known as: Endoxan

1

Liposomal-encapsulated doxorubicin 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.

Also known as: Myocet

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 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

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)
• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

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; Cardiotoxicity

Interventions

Cyclophosphamide; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

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: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

GR (11)