CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Chemotherapy +1 moredrug
Likely dose
Chemotherapy 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01470417
NCT01470417Phase 2Completed

GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

University of Florida·interventional·Posted Nov 11, 2011·Updated Aug 22, 2023

In Brief

A Phase 2 clinical trial evaluating Chemotherapy and Chemotherapy + ChemoRadiotherapy for Pancreatic Cancer. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2014
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Chemotherapydrug

Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.

Chemotherapy + ChemoRadiotherapydrug

Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.