Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: nab-paclitaxel; Gemcitabine
Intervention description: nab-paclitaxel at 125 mg/m^2, by IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes); Gemcitabine at 1000 mg/m^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; Metastatic pancreatic cancer; treatment for pancreatic cancer; Abraxane clinical research trials; Celgene clinical research trials

Summary:

      The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined
      with gemcitabine in Chinese patients with metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has definitive histologically or cytologically confirmed metastatic pancreatic
             adenocarcinoma (Islet cell neoplasms are excluded) that is measurable by Response
             Evaluation criteria for solid tumors (RECIST V1.0)

          2. Patients must have received no previous radiotherapy, surgery, chemotherapy or
             investigational therapy for the treatment of metastatic pancreatic cancer. Prior
             treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation
             sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed
             since completion of the last dose and no lingering toxicities are present. Patients
             having received cytotoxic doses of gemcitabine or any other chemotherapy in the
             adjuvant setting are not eligible for this study

          3. Patient has a Karnofsky performance status (KPS) ≥ 70

          4. Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to starting
             Cycle 1 Day 1. NOTE: the clock for this time interval starts with the date of last
             evaluation confirming pancreatic metastatic disease (either biopsy or imaging results)

          5. Patients should be asymptomatic for jaundice prior to Cycle 1 Day 1. Significant or
             symptomatic amounts of ascites should be drained prior to Cycle 1 Day 1. Pain symptoms
             should be stable and should not require modifications in analgesic management prior to
             Cycle 1 Day 1

          6. Patient has adequate blood counts at screening (obtained ≤ 14 days prior to starting
             Cycle 1 Day 1):

               -  Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;

               -  Platelet count ≥ 100,000/mm^3 (100 × 10^9/L);

               -  Hemoglobin (Hgb) ≥ 9 g/dL

          7. Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days
             prior to starting Cycle 1 Day 1):

               -  Aspartate aminotransferase (SGOT) and alanine transaminase (SGPT) are ≤ 2.5 upper
                  limit of normal (ULN) range, unless liver metastases are clearly present, then ≤
                  5 × upper limit of normal (ULN) range is allowed

               -  Total bilirubin ≤ upper limit of normal range

               -  Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73
                  m^2 for patients with serum creatinine levels above or below the institutional
                  normal value. If using creatinine clearance, actual body weight should be used
                  for calculating creatinine clearance (eg, using the Cockcroft-Gault formula). For
                  patients with a body mass index (BMI) > 30 kg/m^2, lean body weight should be
                  used instead.

          8. The patient has acceptable coagulation studies (obtained ≤14 days prior to starting
             Cycle 1 Day 1) as demonstrated by prothrombin time (PT) and partial thromboplastin
             time (PTT) within normal limits (WNL) ±15%.

          9. The patient has no clinically significant abnormalities in urinalysis results
             (obtained ≤14 days prior to starting Cycle 1 Day 1).

         10. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of
             signing the informed consent document.

               -  If a female patient is of child-bearing potential, as evidenced by regular
                  menstrual periods, she must have a negative pregnancy test (e.g. serum β-subunit
                  of human chorionic gonadotropin (β-hCG) documented prior to the first
                  administration of study drug.

               -  If sexually active, the patient must agree to use contraception considered
                  adequate and appropriate by the Investigator during the period of administration
                  of study drug. In addition, male and female patients must utilize contraception
                  after the end of treatment as recommended in the product's

         11. Patient has been informed about the nature of the study, and has agreed to participate
             in the study, and signed the Informed Consent Form prior to participation in any
             study-related activities.

         12. Able to adhere to the study visit schedule and other protocol requirements.

        Exclusion Criteria:

          1. Patient has known brain metastases

          2. Patient has only locally advanced disease.

          3. Patient has a ≥ 20% decrease in serum albumin level between Screening visit and within
             72 hours prior to Cycle 1 Day 1.

          4. History of malignancy in the last 5 years (including chronic leukemias). Patients with
             prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
             Patients with other malignancies are eligible if they were cured by surgery alone or
             surgery plus radiotherapy and have been continuously disease-free for at least 5
             years.

          5. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
             systemic therapy.

          6. Patient has known infection with human immunodeficiency virus, and/or active infection
             with hepatitis B, or hepatitis C (patients with known historical infection with
             hepatitis B or C should be discussed with the Sponsor).

          7. Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done
             to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
             Day 1 of treatment in this study.

          8. Patient that has a history of 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, seizure disorder or clinically significant cardiac
             dysrhythmia or ECG abnormality, within 6 months prior to Cycle 1 Day 1

          9. Patient has a history of allergy or hypersensitivity to any of the study drugs or any
             of their excipients, or the patient exhibits any of the adverse events .

         10. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).

         11. Patients with a history of interstitial lung disease, history of slowly progressive
             dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,
             pulmonary hypersensitivity pneumonitis or multiple allergies.

         12. Patient has any condition, including serious medical risk factors, medical conditions,
             laboratory abnormalities or psychiatric disorders, which could compromise the
             patient's safety or the study data integrity.

         13. Patient is enrolled in any other clinical protocol or investigational trial with an
             interventional agent or assessments that may interfere with study procedures.

         14. Patient is unwilling or unable to comply with study procedures, or is planning to take
             vacation for 7 or more consecutive days during the treatment phase of the study.