Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer|
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 Months ] [ Designated as safety issue: No ]ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.
|Study Start Date:||February 2001|
|Study Completion Date:||November 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Liposomal Doxorubicin
Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.
Drug: Liposomal Doxorubicin
Other Name: Doxil
Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle
Other Name: Taxotere
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Liposomal Doxorubicin
For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|