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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Pancreatic Cancer
Intervention	Drug: Abraxane
Phase	Phase 2
Sponsor	University of Miami Sylvester Comprehensive Cancer Center
Responsible Party	University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier	NCT00691054
First Received	June 4, 2008
Last Updated	November 18, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	June 4, 2008
Last Updated Date	November 18, 2013
Start Date	June 2008
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	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
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
Brief Summary	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.
Detailed Description	OBJECTIVES: Primary - 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. Secondary - 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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Pancreatic Cancer
Intervention	Drug: Abraxane 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 Names: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Study Arm (s)	Experimental: Single Arm

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	20
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012
Eligibility Criteria	DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic cancer - Locally advanced (unresectable) or metastatic disease - Must have failed first-line treatment with a gemcitabine hydrochloride-containing regimen - Measurable or nonmeasurable disease by RECIST criteria PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 3 months - Neutrophils ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 9.0 g/dL - Serum creatinine ≤ 1.5 mg/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT and AST ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy ≥ grade 2 - No clinical AIDS or known positive HIV serology - No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years - No unstable angina - No New York Heart Association class II-IV congestive heart failure - No myocardial infarction within the past 3 months - No stroke within the past 3 months - No significant traumatic injury within the past 28 days - No serious medical or psychiatric illness that would render chemotherapy unsafe PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - More than 3 weeks since prior chemotherapy - More than 2 weeks since prior radiotherapy - More than 4 weeks since prior major surgery or open biopsy - More than 4 weeks since prior experimental drug - At least 3 weeks since other prior therapy - No concurrent major surgery - No concurrent radiotherapy - No other concurrent chemotherapy, immunotherapy, or antitumor hormonal therapy
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States, Singapore

Administrative Information[ + expand ][ + ]

NCT Number	NCT00691054
Other Study ID Numbers	UMIAMI-20080055
Has Data Monitoring Committee	Yes
Information Provided By	University of Miami Sylvester Comprehensive Cancer Center
Study Sponsor	University of Miami Sylvester Comprehensive Cancer Center
Collaborators	Not Provided
Investigators	Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer CenterPrincipal Investigator: Gilberto Lopes, MD Johns Hopkins University
Verification Date	November 2013

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