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: Overall survival will be measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. ] [ Designated as safety issue: No ]Overall survival will be 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.
- Complete, partial, and overall response rate and duration of response in patients with measurable disease [ Time Frame: Per protocol criteria ] [ Designated as safety issue: No ]
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.
Duration of stable disease: In patients who do not achieve CR or PR, the duration of SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started (interval for SD is 2 months).
- CA 19-9 response [ Time Frame: Greater than 30% reduction in the baseline CA 19-9 level at any time on study. ] [ Designated as safety issue: No ]Greater than 30% reduction in the baseline CA 19-9 level at any time on study.
- Progression-free survival [ Time Frame: Progression-free survival will be measured from start of treatment (date of first dose of Abraxane® therapy) to the earliest date of documented disease progression. ] [ Designated as safety issue: No ]
- Safety and toxicity profile [ Time Frame: Duration of treatment ] [ Designated as safety issue: Yes ]
|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|