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Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC) (LAPACT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02301143
First Posted: November 25, 2014
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

Condition Intervention Phase
Pancreatic Neoplasms Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Chemoradiation Drug: Capecitabine Procedure: Surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: nab1-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: up to 1 year from the time the last patient first treatment ]
    Time after the first dose of study therapy to treatment failure


Secondary Outcome Measures:
  • Disease Control Rate [ Time Frame: up to 6 months from last patient first treatment ]
    the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit

  • Overall Response Rate [ Time Frame: up to 6 months from last patient first treatment ]
    the combined incidence of CR and PR

  • Progression-free Survival [ Time Frame: up to 1 year from last patient last treatment ]
    the time after the first dose of study therapy to disease progression or death (by any cause)"

  • Overall Survival [ Time Frame: up to last patient last visit ]
    the time after the first dose of study therapy to death by any cause

  • Composite Health-related Quality of Life [ Time Frame: up to last patient last treatment ]
    Differences in outcomes from baseline, during treatment, and after treatment for the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQs), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30) and Quality of Life Questionnaires (QLQ-PAN26).

  • Number of Adverse Events [ Time Frame: up to 28 days from last patient last visit ]
    After signing Informed Consent Form (ICF) and until 28 days after the last dose of Investigational Product (IP) or 28-day Follow up Visit, whichever occurs later. Not during survival unless it is a suspected SAE.


Enrollment: 107
Actual Study Start Date: April 21, 2015
Estimated Study Completion Date: June 15, 2018
Estimated Primary Completion Date: October 16, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nab-Paclitaxel plus Gemcitabine

nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject.

  • Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR
  • Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR
  • Surgical intervention
Drug: nab-Paclitaxel
Other Name: Abraxane
Drug: Gemcitabine
Other Name: Gemzar
Drug: Chemoradiation Drug: Capecitabine Procedure: Surgery
Surgical intervention

Detailed Description:

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
  • No prior anticancer therapy for pancreatic cancer

    •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function

  • Signed informed Consent

Exclusion Criteria:

  • Active bacterial, viral, or fungal infection
  • Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
  • Subjects with sensory neuropathy, ascites, or plastic biliary stent.
  • Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
  • Women who are pregnant or breast feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301143


  Show 42 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Teng Jin Ong, MD Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02301143     History of Changes
Other Study ID Numbers: ABI-007-PANC-007
First Submitted: November 14, 2014
First Posted: November 25, 2014
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Celgene:
Pancreatic Neoplasms
Pancreatic Cancer
Locally advanced pacriatic cancer
nab-Paclitaxel
Abraxane
Gemcitabine
ABI-007

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