Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable
      and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.
    

Detailed description: 
      This current study proposes to conduct a prospective non-randomized open-label phase II trial
      using Gemcitabine and Abraxane in the neoadjuvant treatment of resectable and
      borderline-resectable pancreatic cancer. For patients that are low-risk resectable (based on
      prediction rule) the plan is to administer 2 cycles of Gemcitabine and Abraxane followed by
      additional systemic therapy or chemotherapy with radiation therapy (chemoRT), followed by
      surgical resection. For patients who are either borderline-resectable or high-risk resectable
      (see schema), the plan is to administer 2 cycles of Gemcitabine and Abraxane followed by
      chemoradiotherapy concurrent with gemcitabine followed by surgical resection. For those
      without high-risk features, systemic chemotherapy alone will be administered. The primary
      endpoints will be R0 surgical resection rate, biochemical (CA 19-9), pathologic and
      radiologic response rates. Secondary endpoints will include progression-free survival (PFS),
      overall survival (OS), 30-day post-op mortality, toxicity, quality of life, pain control, and
      correlative molecular exploratory analysis involving pancreatic tumor and stromal SPARC
      expression levels. The investigators will also assess the patient, tumor, and clinical
      characteristics that may predict R0 resectability, thus further refining the predictive rule
      in high-risk patients as defined by Bao and colleagues. The investigators' hypothesis is that
      by using targeted and risk-adapted chemotherapy or chemoRT, improved R0 surgical resections
      can be achieved and effective systemic therapy delivered, which will translate to a
      significant improvement in overall survival in patients with pancreatic adenocarcinoma,
      compared to published historical controls.
    

Intervention name(s): Chemotherapy; Chemotherapy + ChemoRadiotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.; Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Other intervention name(s): Abraxane; Gemcitabine; Abraxane; Gemcitabine
Intervention MeSH terms: Gemcitabine; Albumin-Bound Paclitaxel; Paclitaxel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment