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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.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00691054
First received: June 4, 2008
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  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 Intervention Phase
Pancreatic Cancer
 Drug: Abraxane
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691054

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 119074
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center
Principal Investigator: Gilberto Lopes, MD Johns Hopkins University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00691054     History of Changes
Other Study ID Numbers: EPROST-20080055, SCCC-2007096
Study First Received: June 4, 2008
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013