Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Condition: Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Diseases; Endocrine System Diseases; Gemcitabine; Antimetabolites, Antineoplastic
MeSH terms: Neoplasms; Pancreatic Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pancreatic Diseases; Endocrine System Diseases
Intervention: nab-Paclitaxel; Gemcitabine
Intervention description: nab-Paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 866.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Resectable pancreatic cancer; resected; resectable PDA; adenocarcinoma; surgically resected; adjuvant; Abraxane; nab-paclitaxel; ABI-007; gemcitabine; Gemzar; Phase 3

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic
             complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors
             are excluded.

          2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis
             (M) 0.

          3. Subject should be able to start treatment no later than 12 weeks postsurgery.

          4. ≥18 years of age at the time of signing the informed consent form (ICF).

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          6. Acceptable hematology parameters:

               -  Absolute neutrophil count (ANC) ≥1500 cell/mm^3

               -  Platelet count ≥100,000/mm^3

               -  Hemoglobin (Hgb) ≥9 g/dL

          7. 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

          8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization

          9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial
             thromboplastin time (PTT) within normal limits (±15%)

        Exclusion Criteria:

        A subject will not be eligible for inclusion in this study if any of the following criteria
        apply:

          1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma

          2. Presence of or history of metastatic pancreatic adenocarcinoma

          3. 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)

          4. 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

          5. 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

          6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of
             their excipients

          7. 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:

               1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)

               2. History of interstitial lung disease, slowly progressive dyspnea and unproductive
                  cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
                  hypersensitivity pneumonitis or multiple allergies

               3. 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