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A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer

Phase 2
19 Years
Not Enrolling
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer


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 Bryoststin-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.

Inclusion Criteria:

- Histologic proof of adenocarcinoma of the pancreas confirmed at the pathology
department of the enrolling institution; pathologic evidence may include fine needle
aspirate material from sites of distant spread (e.g. liver, lymph- nodes, peritoneum)
in patients with an unambiguous pancreatic tumor (i.e. a likely pancreatic primary)

- Pancreatic cancer, which is locally advanced and considered surgically not resectable
or metastatic pancreatic cancer

- 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; chemotherapy will be
defined to include standard cytotoxic treatments, as well as newer biologic agents
(eg Herceptin, EGFR antagonist, Ras inhibitors)

- Chemo/RT: one prior neo-adjuvant, adjuvant or definitive course of chemo/ RT
(which did not include a taxane), or RT alone will be allowed

- one prior course of chemotherapy alone which did not include a taxane

- Radiotherapy alone

- Specific sequences of prior treatment permissible for study entry:

- Chemo/RT

- RT alone

- Chemo/RT -> progression -> chemotherapy alone (eg gemcitabine)

- One course of chemotherapy alone (eg gemcitabine, or chemo combinations)

- Adjuvant Vaccine -> progression -> chemotherapy alone or chemo/RT

- Patients must have at least one-dimensionally measurable disease; a lesion is
considered measurable if one diameter is >= 20 mm in one dimension by conventional
techniques, or >= 10 mm in one dimension by spiral CT; prior radiotherapy is
allowable; lesions within the prior field of radiation may only be used as indicator
lesions if there has been recent evidence of disease progression at that site,
defined as a 50% increase in longest diameter, or 100% increase in the product of
two-dimensional radiographic evaluation (eg width x depth) since the completion of
radiation therapy

- 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 are ineligible as the effect of the drugs used in this
study on a fetus or newborn child is unknown; a pregnancy test will be performed on
each fertile premenopausal female prior to entry into the study; treatment may not
begin until the results of the pregnancy test are ascertained

- 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

- Any concurrent active malignancy other than non-melanoma skin cancers or
carcinoma-in-situ of the cervix; patients with previous malignancies but without
evidence of disease for > 5 years will be allowed to enter the trial; patients with a
history of a T1a or b prostate cancer (detected incidentally at TURP and comprising
less than 5% of resected tissue) may participate if the PSA remained within normal
limits since TURP removal

- Patients with a history of HIV disease; this is based upon the possible interactions
of the bryostatin-1 or paclitaxel with anti-retroviral medications or possible
immunosuppressive activity of the experimental agents

- 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)

- Patients with more than the permitted number of treatments for their pancreas cancer
will not be allowed to participate; specific treatment sequences that will exclude
patients from study entry are:

- More than one chemotherapy alone regimen (ie gemcitabine -> progression ->

- Any prior treatment with paclitaxel for pancreas cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Associated 95% confidence intervals will be computed and presented.

Outcome Time Frame:

Up to 8 years

Safety Issue:


Principal Investigator

Andreas Kaubisch

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell



Montefiore Medical Center Bronx, New York  10467-2490