Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Did Not Respond to First-Line Therapy With Gemcitabine
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy|
- Overall Survival Rate at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
- Number of Participants Showing Complete or Partial Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Cesponse (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% descrease in the sum of the longest diameter of target lesions; Overal Response (OR) = CR + PR.
- Number of Participants Showing Stable Disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of participants showing stable disease according to RECIST 1.0 criteria
- Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Participants Experiencing Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Median Overall Survival of Participants [ Time Frame: 12 months ] [ Designated as safety issue: No ]Median overall survival rate of participants measured in months
|Study Start Date:||June 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Other Name: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
- To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen.
- To determine the safety and characterize the toxicity profile of this drug.
- To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease.
- To determine CA 19-9 response.
- To determine progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Johns Hopkins Singapore International Medical Centre|
|Singapore, Singapore, 119074|
|Study Chair:||Caio Max S. Rocha Lima, MD||University of Miami Sylvester Comprehensive Cancer Center|
|Principal Investigator:||Gilberto Lopes, MD||Johns Hopkins University|