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

September 3, 2007
June 29, 2011
February 2004
June 2009   (final data collection date for primary outcome measure)
Non-progression rate after 6 cycles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Non-progression rate after 6 cycles [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00524810 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer
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

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • 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
Experimental: Caelyx - Taxotere
Interventions:
  • Drug: Pegylated liposomal doxorubicin
  • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00524810
CAPYTTOLE
No
Douglas Micheau, ARCAGY-GINECO
ARCAGY/ GINECO GROUP
Not Provided
Principal Investigator: Laure CHAUVENET, MD, PHD Hôpital HOTEL DIEU - Paris
ARCAGY/ GINECO GROUP
June 2011

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