CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Nab paclitaxel +1 moredrug
Likely dose
Nab-paclitaxel 125 mg/m² IV on days 1, 8, and 15 of every 28-day cycle; plus gemcitabine (dose specified in truncated text)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma
  • ✓No evidence of distant metastasis/stage IV disease
  • ✓Age >18 years
  • ✓ECOG performance status 0 or 1
Key exclusion· 11
  • ✕Locally advanced surgically unresectable PDAC
  • ✕Evidence of distant metastatic PDAC
  • ✕Prior chemotherapy or radiation therapy for pancreatic adenocarcinoma
  • ✕Major surgery within 4 weeks of starting study drug

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

Search/NCT02723331
NCT02723331Phase 2Completed
CompareCT.gov

Perioperative Therapy for Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Academic Thoracic Oncology Medical Investigators Consortium·interventional·Posted Mar 30, 2016·Updated Jul 1, 2025

In Brief

A Phase 2 clinical trial evaluating Nab paclitaxel and Gemcitabine for Pancreatic Cancer and 2 related conditions. Completed, enrolled 48 participants across 4 sites.

Detailed Summary

The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer, Pancreatic Adenocarcinoma, Pancreas Ductal Adenocarcinoma
CountriesUnited States
CollaboratorsCelgene Corporation, Criterium, Inc., University of Colorado, Denver

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartDec 30, 2016
Primary CompletionDec 8, 2022
Study CompletionDec 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 10.3 years ago

Interventions

Nab paclitaxeldrug

Nab-paclitaxel and gemcitabine, for R-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Gemcitabinedrug

Nab-paclitaxel and gemcitabine, for BR-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.