At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 32 enrolled

Drug / intervention

Gemcitabine, docetaxel, and capecitabine +1 moredrug

Likely dose

Gemcitabine, docetaxel, and capecitabine 1500 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/NCT00869258

NCT00869258Phase 2Completed

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Phase II Study for Inoperable Non-Metastatic Pancreatic Cancer (Stage IVA) With Neoadjuvant Gemzar, Taxotere and Xeloda (GTX), and Radiation With Gemzar

Columbia University·interventional·Posted Mar 25, 2009·Updated Jun 22, 2016

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, docetaxel, and capecitabine and Radiation therapy with gemzar for Pancreatic Cancer Stage IVA. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether an experimental drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPancreatic Cancer Stage IVA

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2005

First PostedMar 2009

Primary CompletionOct 2014

TodayJul 2026

First PostedMar 25, 2009

Enrollment StartJun 1, 2005

Primary CompletionOct 1, 2014

TodayJul 2, 2026

Enrollment to primary: 9.3 yearsPosted 17.3 years ago

Interventions

Gemcitabine, docetaxel, and capecitabinedrug

Day 1-14: Capecitabine 1500 mg/m2/day (+/- 2days) Day 4 and 11: Gemcitabine 750 mg/m2/day (+/- 2days) Day 4 and 11: Docetaxel 30 mg/m2/day (+/- 2 days) Two week treatment regimen is followed by one week off, repeated for a total of 3 cycles

Radiation therapy with gemzarradiation

Starting on week 12 +/- 5 days radiation therapy will be given in the standard manner over 5 weeks with daily radiation fractions Monday through Friday. Once a week gemcitabine will be given IV over 30 minutes at 250-300 mg/m2