Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

October 28, 2014 updated by: ARCAGY/ GINECO GROUP

Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.

Secondary

  • Determine the feasibility of this drug in these patients.
  • Evaluate chemotherapy-induced toxicities in these patients.
  • Assess the disease-free survival and overall survival of these patients.
  • Study the geriatric covariates.
  • Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.

After completion of study therapy, patients are followed up periodically for 2 years.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75181
        • Hotel Dieu de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast

    • Metastatic disease as confirmed by ≥ 1 of the following:

      • Histology or cytology
      • Radiology
      • Elevated CA 15-3 levels
  • No HER2/neu overexpression by IHC or FISH

  • Measurable (≥ 10 mm) or evaluable disease

    • Bone lesions or isolated pleural effusion allowed
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Postmenopausal
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 5 times ULN
  • Bilirubin ≤ 2 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • LVEF ≥ 50%
  • No congestive heart failure or other uncontrolled cardiac disease
  • No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
  • No prior hypersensitivity to anthracyclines
  • No psychological, familial, social, or geographical reason that would preclude study follow-up
  • No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease

  • Prior adjuvant chemotherapy allowed

    • No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
  • No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
  • More than 30 days since prior participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
Drug: pegylated liposomal doxorubicin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 3 and 6 cures
3 and 6 cures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Laure Chauvenet, MD, Hotel Dieu de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633600
  • ARCAGY-DOGMES
  • ARCAGY-GINECO-BR106
  • INCA-RECF0511
  • EUDRACT-2007-002736-28
  • SCHER-ARCAGY-DOGMES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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