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

NCT ID: NCT02301143

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-21
• Study Completion Date: 2018-04-26

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

nab-Paclitaxel

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Chemoradiation

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Surgery

Intervention Type: PROCEDURE

Surgical intervention

Interventions

nab-Paclitaxel

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Chemoradiation

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Surgery

Surgical intervention

Intervention Type: PROCEDURE

Other Intervention Names

Abraxane; Gemzar

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teng Jin Ong, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Mayo Clinic - Arizona

Scottsdale, Arizona, United States

UC Davis Cancer Center

Sacramento, California, United States

Scripps Clinic Torrey Pines

San Diego, California, United States

Smilow Cancer Hospital At Yale-New Haven

New Haven, Connecticut, United States

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Piedmont Cancer Institute PC

Atlanta, Georgia, United States

Cancer Treatment Centers of America - Southeastern Regional Medical Center

Newnan, Georgia, United States

ME Center for Cancer Medicine

Scarborough, Maine, United States

Tufts - New England Medical Center

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Saint Joseph Mercy Ann Arbor Hospital

Ann Arbor, Michigan, United States

Karmanos Cancer Center Wayne State University

Detroit, Michigan, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Regional Cancer Care Associates LLC

Morristown, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Clinical Research Alliance

Lake Success, New York, United States

State University of New York Upstate Medical Center

Syracuse, New York, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Mark H Zangmeister Center

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Tom Baker Cancer Center

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

CHUM Hôpital Saint-Luc

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Centre Regional de lutte contre le cancer Paul Papin

Angers, , France

CHRU Besancon

Besançon, , France

Centre Hospitalier Belfort Montbeliard

Besançon, , France

Hopital Beaujon

Clichy, , France

Hopital Saint Antoine

Paris, , France

Hopital Haut Leveque

Pessac, , France

Ospedale Sacro Cuore di Gesu FatebeneFratelli

Benevento, , Italy

Azienda Ospedaliera Universitaria San Martino

Genova, , Italy

Policlinico Universitario Campus Biomedico Di Roma

Roma, , Italy

Hospital Universitario a Coruna

A Coruña, , Spain

ICO-Hospital Germans Trias i Pujol

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

United States; Canada; France; Italy; Spain

References

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.

Reference Type: DERIVED

PMID: 31953079 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ABI-007-PANC-007

Identifier Type: -

Identifier Source: org_study_id