ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer|
- Proportion of Patients With Confirmed Responses [ Time Frame: Two consecutive evaluations at least 6 weeks apart ] [ Designated as safety issue: No ]
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.
Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
- Progression-free Survival [ Time Frame: Time from registration to progression or death (up to 5 years) ] [ Designated as safety issue: No ]Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
- Overall Survival [ Time Frame: Death or last follow-up (up to 5 years) ] [ Designated as safety issue: No ]Overall survival time was defined as the number of days from registration to the date of death or last follow-up
- Adverse Event [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
|Study Start Date:||August 2005|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Name: GemzarDrug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Name: nab (nanoparticle albumin-bound)-Paclitaxel, Abraxane
- Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.
- Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.
* Determine the time to disease progression and survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110084
Show 201 Study Locations
|Study Chair:||Vivek Roy, MD, FACP||Mayo Clinic|
|Study Chair:||Philip J. Stella, MD||CCOP - Michigan Cancer Research Consortium|
|Principal Investigator:||Tom R. Fitch, M.D.||Mayo Clinic|
|Principal Investigator:||Timothy J. Hobday, M.D.||Mayo Clinic|