Clinical Trial: Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response Rate of at Least 30% [ Time Frame: 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).


Original Primary Outcome:

Current Secondary Outcome:

  • Adverse Events [ Time Frame: Up to 8 years ]
    95% confidence intervals will be computed and presented.
  • Overall Survival [ Time Frame: Up to 8 years ]
    Computed using the Kaplan-Meier estimator.
  • Bryostatin 1 Pharmacokinetics [ Time Frame: Week 1 ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 8, 2002
Date Started: January 2002
Date Completion:
Last Updated: April 8, 2015
Last Verified: May 2013