Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

Completed · Phase 3

Conditions studied: Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Pancreatic Diseases, Digestive System Diseases, Endocrine System Diseases, Gemcitabine, Antimetabolites, Antineoplastic

In brief

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

Key facts

Study ID

NCT01964430

Run by

Celgene

People needed

866

Starts

2014-03-28

Expected to finish

2022-06-30

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
• Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
• Subject should be able to start treatment no later than 12 weeks postsurgery.
• ≥18 years of age at the time of signing the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Acceptable hematology parameters:
• Absolute neutrophil count (ANC) ≥1500 cell/mm\^3
• Platelet count ≥100,000/mm\^3
• Hemoglobin (Hgb) ≥9 g/dL
• Acceptable blood chemistry levels:
• Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
• Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
• Alkaline phosphatase ≤ 2.5 x ULN
• Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m\^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
• Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
• Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)

You may not qualify if…

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
• Presence of or history of metastatic pancreatic adenocarcinoma
• Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
• Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
• History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
• History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
• History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
• History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder

Where it is running

• Mayo Clinic - Arizona — Scottsdale, Arizona, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• Local Institution - 044 — Sacramento, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• Local Institution - 001 — San Francisco, California, United States
• University of California, San Francisco Cutaneous Oncology and Melanoma Center — San Francisco, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Local Institution - 059 — Denver, Colorado, United States
• Rocky Mountain Cancer Centers, LLP [Denver-Midtown] — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Local Institution - 022 — Boca Raton, Florida, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• Florida Cancer Institute Cancer Spec — Fort Myers, Florida, United States
• Local Institution - 031 — Fort Myers, Florida, United States
• Gainesville Heme Oncology Associates — Gainesville, Florida, United States
• Local Institution - 011 — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami and Sylvester Cancer Center — Miami, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Local Institution - 039 — Orlando, Florida, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• Georgia Cancer Specialist — Atlanta, Georgia, United States
• Local Institution - 043 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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