Clinical trial NCT02301143: Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Official title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic Neoplasms
Pancreatic Cancer
Locally advanced pacriatic cancer
nab-Paclitaxel
Abraxane
Gemcitabine
ABI-007
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
timeFrame: Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)
Secondary outcomes:
measure: Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1
timeFrame: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
measure: Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1
timeFrame: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
measure: Kaplan-Meier Estimate of Progression-Free Survival (PFS)
timeFrame: Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)
measure: Kaplan-Meier Estimates for Overall Survival (OS)
timeFrame: Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)
measure: Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales
timeFrame: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
measure: Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items
timeFrame: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
measure: Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales
timeFrame: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
measure: Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale
timeFrame: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
measure: Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores
timeFrame: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
measure: Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 of study drug up to end of the study; up to 31.3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Diego
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital At Yale-New Haven
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute PC
state: Georgia
city: Newnan
country: United States
facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center
state: Georgia
city: Scarborough
country: United States
facility: ME Center for Cancer Medicine
state: Maine
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Ann Arbor Hospital
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center Wayne State University
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Einstein Cancer Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Columbus
country: United States
facility: Mark H Zangmeister Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Montreal
country: Canada
facility: CHUM Hôpital Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Angers
country: France
facility: Centre Regional de lutte contre le cancer Paul Papin
city: Besançon
country: France
facility: CHRU Besancon
city: Besançon
country: France
facility: Centre Hospitalier Belfort Montbeliard
city: Clichy cedex
country: France
facility: Hopital Beaujon
city: Paris
country: France
facility: Hopital Saint Antoine
city: Pessac Cedex
country: France
facility: Hopital Haut Leveque
city: Benevento
country: Italy
facility: Ospedale Sacro Cuore di Gesu FatebeneFratelli
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma
city: A Coruna
country: Spain
facility: Hospital Universitario a Coruna
city: Barcelona
country: Spain
facility: ICO-Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Celgene
name: Teng Jin Ong, MD
role: STUDY_DIRECTOR
References:
citation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.