Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage III Pancreatic Cancer

Duct Cell Adenocarcinoma of the Pancreas

Stage IV Pancreatic Cancer

Recurrent Pancreatic Cancer

Acinar Cell Adenocarcinoma of the Pancreas

Treatments

Drug: paclitaxel

Drug: bryostatin 1

Study type

Interventional

Funder types

NIH

Identifiers

NCT00031694

N01CM17103 (U.S. NIH Grant/Contract)

NCI-5624 (Other Identifier)

NCI-2012-03003

01-09-224 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.

II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.

OUTLINE: This is an open-label, multicenter study.

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.

Enrollment

19 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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)