CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
pralatrexate +3 moredrug
Likely dose
pralatrexate 120 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/NCT01129206
NCT01129206Phase 2Completed

Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.

Ohio State University Comprehensive Cancer Center·interventional·Posted May 24, 2010·Updated Jun 1, 2016

In Brief

A Phase 2 clinical trial evaluating pralatrexate, docetaxel, and 2 other interventions for Adenocarcinoma of the Esophagus and 4 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago

Interventions

pralatrexatedrug

IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxeldrug

Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18radiation

Correlative studies

positron emission tomographyprocedure

Correlative studies