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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

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

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Douglas Micheau, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT00524810     History of Changes
Other Study ID Numbers: CAPYTTOLE
Study First Received: September 3, 2007
Last Updated: June 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
 Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013