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Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524810
First Posted: September 5, 2007
Last Update Posted: June 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ARCAGY/ GINECO GROUP
  Purpose
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Condition Intervention Phase
Metastatic Breast Cancer Drug: Pegylated liposomal doxorubicin Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Non-progression rate after 6 cycles [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 67
Study Start Date: February 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caelyx - Taxotere 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524810


Locations
France
Hôpital HOTEL DIEU
Paris, France, 75004
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Laure CHAUVENET, MD, PHD Hôpital HOTEL DIEU - Paris
  More Information

Responsible Party: Douglas Micheau, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT00524810     History of Changes
Other Study ID Numbers: CAPYTTOLE
First Submitted: September 3, 2007
First Posted: September 5, 2007
Last Update Posted: June 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors