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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

This study has been completed.
Information provided by (Responsible Party):
University of Miami Identifier:
First received: June 4, 2008
Last updated: December 14, 2016
Last verified: December 2016

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 Intervention Phase
Pancreatic Cancer
Drug: Abraxane
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Overall Survival Rate at 6 Months [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures:
  • Number of Participants Showing Complete or Partial Response [ Time Frame: 6 months ]
    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 ]
    Number of participants showing stable disease according to RECIST 1.0 criteria

  • Progression-free Survival [ Time Frame: 6 months ]
    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 ]
  • Median Overall Survival of Participants [ Time Frame: 12 months ]
    Median overall survival rate of participants measured in months

Enrollment: 20
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 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 Name: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00691054

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
Sponsors and Collaborators
University of Miami
Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center
Principal Investigator: Gilberto Lopes, MD Johns Hopkins Singapore International Medical Centre
  More Information

Responsible Party: University of Miami Identifier: NCT00691054     History of Changes
Other Study ID Numbers: 20080055
Study First Received: June 4, 2008
Results First Received: September 3, 2013
Last Updated: December 14, 2016

Keywords provided by University of Miami:
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on April 26, 2017