Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Carcinoma, Acinar Cell
Intervention: paclitaxel; bryostatin 1
Intervention description: Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Bryostatin 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in
      treating patients who have locally advanced unresectable or metastatic pancreatic cancer.
      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells
      more sensitive to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of adenocarcinoma of the pancreas that is locally advanced and
             considered surgically not resectable or metastatic

          -  Patients with or without prior treatment are eligible for treatment on protocol; prior
             treatment may have included one treatment course of chemo/RT and/ or one course of
             chemotherapy, but not two prior courses of chemotherapy;

          -  Measurable disease

          -  ECOG performance status of 0-1

          -  Ability to sign an informed consent form indicating awareness of the investigational
             nature of this study, in keeping with the policies of the hospital

          -  Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or
             radiotherapy; the most recent treatment for pancreatic cancer, within the limitations
             of allowed prior therapy must be 28 days or longer prior to enrollment on study

          -  Absolute granulocytes > 1,500/mm^3

          -  Platelets > 150,000/mm^3

          -  Serum bilirubin < 1.5 mg/dl

          -  Serum creatinine < 1.5 mg/dl

        Exclusion Criteria:

          -  Presence of any ongoing toxic effect from prior treatment

          -  Brain metastases

          -  History of active angina or myocardial infarction within 6 months; history of
             significant ventricular arrhythmia requiring medication with antiarrhythmics; well
             controlled atrial fibrillation on standard management will be permitted

          -  Pregnant or lactating women

          -  Pre-existing neurotoxicity that is graded 3+ or greater

          -  Serious intercurrent infections, or nonmalignant medical illnesses that are
             uncontrolled or whose control may be jeopardized by the complications of this therapy

          -  Psychiatric disorders rendering patients incapable of complying with the requirements
             of the protocol

          -  HIV infection

          -  Any other medical condition or reason that, in the investigator's opinion, makes the
             patient unsuitable to participate in a clinical trial (for example a history of prior
             poor compliance with treatment)