CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
paclitaxel +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed adenocarcinoma of the pancreas that is locally advanced and surgically unresectable or metastatic
  • ✓ECOG performance status 0-1
  • ✓Measurable disease
  • ✓At most one prior chemotherapy course (or one combined chemotherapy/radiotherapy course), but not two prior chemotherapy regimens
Key exclusion· 7
  • ✕Brain metastases
  • ✕Pre-existing neurotoxicity grade ≥3
  • ✕History of myocardial infarction or active angina within 6 months
  • ✕Significant ventricular arrhythmia requiring antiarrhythmic medication (atrial fibrillation well-controlled on standard management allowed)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00031694
NCT00031694Phase 2Completed
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Jun 11, 2021

In Brief

A Phase 2 clinical trial evaluating paclitaxel and bryostatin 1 for Acinar Cell Adenocarcinoma of the Pancreas and 4 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2002
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 23.4 years ago

Interventions

paclitaxeldrug

Given IV

bryostatin 1drug

Given IV