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

NCT ID: NCT00960336

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Group Type: EXPERIMENTAL

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Interventions

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure Chauvenet, MD

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu de Paris

Locations

Hotel Dieu de Paris

Paris, , France

Countries

France

References

Falandry C, Brain E, Bonnefoy M, Mefti F, Jovenin N, Rigal O, Guillem O, El Kouri C, Uwer L, Abadie-Lacourtoisie S, Cretin J, Jacquin JP, Paraiso D, Freyer G. Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial. Eur J Cancer. 2013 Sep;49(13):2806-14. doi: 10.1016/j.ejca.2013.04.027. Epub 2013 Jun 1.

Reference Type: DERIVED

PMID: 23735702 (View on PubMed)

Other Identifiers

ARCAGY-DOGMES

Identifier Type: -

Identifier Source: secondary_id

ARCAGY-GINECO-BR106

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0511

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-002736-28

Identifier Type: -

Identifier Source: secondary_id

SCHER-ARCAGY-DOGMES

Identifier Type: -

Identifier Source: secondary_id

CDR0000633600

Identifier Type: -

Identifier Source: org_study_id