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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Pancreatic Neoplasms	Drug: nab-Paclitaxel; Drug: Gemcitabine; Drug: Chemoradiation; Drug: Capecitabine; Procedure: Surgery	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	107 participants
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).
Actual Study Start Date :	April 21, 2015
Actual Primary Completion Date :	November 21, 2017
Estimated Study Completion Date :	April 26, 2018

Arms and Interventions

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Arm

Intervention/treatment

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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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
2. Overall Response Rate [ Time Frame: up to 6 months from last patient first treatment ]
   the combined incidence of CR and PR
3. 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)"
4. Overall Survival [ Time Frame: up to last patient last visit ]
   the time after the first dose of study therapy to death by any cause
5. 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).
6. 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.

Eligibility Criteria

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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

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  Show 42 Study Locations

Sponsors and Collaborators

Celgene

Investigators

Study Director:	Teng Jin Ong, MD	Celgene

More Information

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Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT02301143 History of Changes
Other Study ID Numbers:	ABI-007-PANC-007
First Posted:	November 25, 2014
Last Update Posted:	April 25, 2018
Last Verified:	April 2018

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