Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031694
• Other study ID #: NCI-2012-03003
• Secondary ID: 01-09-224NCI-562
• Status: Completed
• Phase: Phase 2
• Start date: March 2002
• Est. completion date: April 2010

Study information

• Verified date: May 2021
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• paclitaxel
Given IV
• bryostatin 1
Given IV

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lam AP, Sparano JA, Vinciguerra V, Ocean AJ, Christos P, Hochster H, Camacho F, Goel S, Mani S, Kaubisch A. Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. Am J Clin Oncol. 2010 Apr;33(2):121 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bryostatin 1 Pharmacokinetics	Not done-study terminated early	Week 1
Primary	Response Rate of at Least 30%	Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).	Up to 8 years
Secondary	Number of Participants With Adverse Events		Up to 8 years
Secondary	Overall Survival	Computed using the Kaplan-Meier estimator.	Up to 8 years