Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Duct Cell Adenocarcinoma of the Pancreas; Stage IV Pancreatic Cancer; Acinar Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer
• Interventions: Drug: paclitaxel; Drug: bryostatin 1

• Registration Number: NCT00031694
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2015-04-08
• Results First Submitted QC: 2015-04-08
• Results First Posted: 2015-04-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (paclitaxel, bryostatin 1)	paclitaxel	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.
Treatment (paclitaxel, bryostatin 1)	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.

Primary Outcome Measures

Name	Time	Method
Response Rate of at Least 30%	Up to 8 years	Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 8 years
Overall Survival	Up to 8 years	Computed using the Kaplan-Meier estimator.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States