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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960336
• Other study ID #: CDR0000633600
• Secondary ID: ARCAGY-DOGMESARC
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2009
• Last updated: October 28, 2014
• Start date: March 2008

Study information

• Verified date: October 2014
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
France	Hotel Dieu de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		3 and 6 cures	Yes