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Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami
ClinicalTrials.gov Identifier:
NCT00691054
First received: June 4, 2008
Last updated: April 4, 2017
Last verified: April 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 Response (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall 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: 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.
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 to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
  2. Patients have to be 18 years-old or older
  3. Able to give signed Informed consent
  4. Adequate end-organ function with laboratory parameters as follows:

    • Neutrophils: 1.5 x10^9/L or greater
    • Plts: 100 x10^9/L or greater
    • Hemoglobin: ≥ 9.0g/dL
    • Serum Creatinine: ≤ 1.5mg/dL
    • Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
    • Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
  5. Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
  6. Measurable or non-measurable disease by RECIST criteria
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  8. Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
  9. Life expectancy greater than 3 months
  10. Willing and able to comply with the protocol requirement.
  11. Patients must not have any peripheral neuropathy equal or greater than grade 2

Exclusion Criteria:

  1. Chemotherapy within 3 weeks prior to enrollment
  2. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
  3. Any major surgery within 4 weeks prior to enrollment
  4. Peripheral neuropathy equal to or greater than grade 2
  5. Clinical AIDS or known positive HIV serology
  6. Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
  7. Unstable angina
  8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  9. History of myocardial infarction within 3 months
  10. History of stroke within 3 months
  11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
  12. Pregnant (positive pregnancy test) or lactating
  13. Inability to comply with study and/or follow-up procedures
  14. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
  15. Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
  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 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
Investigators
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

Publications:
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00691054     History of Changes
Other Study ID Numbers: 20080055
SCCC-2007096 ( Other Identifier: UMiami Sylvester Comprehensive Cancer Center )
Study First Received: June 4, 2008
Results First Received: September 3, 2013
Last Updated: April 4, 2017

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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
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

ClinicalTrials.gov processed this record on August 17, 2017