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Trial record 10 of 12 for:    "Breast Ductal Carcinoma" | "Topoisomerase Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT00960336
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date October 29, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Response rate [ Time Frame: 3 and 6 cures ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
Response rate
Change History Complete list of historical versions of study NCT00960336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: pegylated liposomal doxorubicin hydrochloride
Study Arms  ICMJE Experimental: single arm
Intervention: Drug: pegylated liposomal doxorubicin hydrochloride
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2014)
59
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2009)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960336
Other Study ID Numbers  ICMJE CDR0000633600
ARCAGY-DOGMES
ARCAGY-GINECO-BR106
INCA-RECF0511
EUDRACT-2007-002736-28
SCHER-ARCAGY-DOGMES
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ARCAGY/ GINECO GROUP
Study Sponsor  ICMJE ARCAGY/ GINECO GROUP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laure Chauvenet, MD Hotel Dieu de Paris
PRS Account ARCAGY/ GINECO GROUP
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP