Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

This study has been completed.

Sponsor:

Information provided by:

ARCAGY/ GINECO GROUP

ClinicalTrials.gov Identifier:

NCT00524810

First received: September 3, 2007

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2007

Last Updated Date

June 29, 2011

Start Date ^ICMJE

February 2004

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non-progression rate after 6 cycles [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Non-progression rate after 6 cycles [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00524810 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

tolerance and toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Tumor response and duration [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

tolerance and toxicity [ Time Frame: 6 months ]
Tumor response and duration [ Time Frame: 5 years ]
Time to Progression [ Time Frame: 5 years ]
Overall survival [ Time Frame: 5 years ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Official Title ^ICMJE

A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer

Brief Summary

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Detailed Description

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: Pegylated liposomal doxorubicin
Caelyx 30 mg/m² day 1 every 3 weeks

Other Name: Caelyx
Drug: Docetaxel
Taxotere 75 mg/m² day 2 every 3 weeks

Other Name: Taxotere

Study Arm (s)

Experimental: Caelyx - Taxotere

Interventions:

Drug: Pegylated liposomal doxorubicin
Drug: Docetaxel

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

first metastatic chemo line
presence of measurable or bone lesion
at least one lesion outside the radiated areas
can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

Exclusion Criteria:

only local tumoral progression
symptomatic cerebral metastasis
neuropathy > NCI-CTC 2
previous cancer within 10 years _ previous cancer within 10 years

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00524810

Other Study ID Numbers ^ICMJE

CAPYTTOLE

Has Data Monitoring Committee

Responsible Party

Douglas Micheau, ARCAGY-GINECO

Study Sponsor ^ICMJE

ARCAGY/ GINECO GROUP

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Laure CHAUVENET, MD, PHD

Hôpital HOTEL DIEU - Paris

Information Provided By

ARCAGY/ GINECO GROUP

Verification Date

June 2011

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

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