Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer
About this trial
This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas
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)
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (paclitaxel, bryostatin 1)
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.