CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 94 enrolled / 94 target
Drug / intervention
Cixutumumab +3 morebiological
Likely dose
Not stated in 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/NCT01142388
NCT01142388Phase 2ActiveUpdate Overdue (0.5/mo)Completion was 143mo ago

Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer

National Cancer Institute (NCI)·interventional·Posted Jun 11, 2010·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating Cixutumumab, Laboratory Biomarker Analysis, and 2 other interventions for Metastatic Esophageal Adenocarcinoma and 7 related conditions. Active but no longer recruiting, targeting 94 participants across 232 sites.

Signals

Enrollment appears stalled

Detailed Summary

This randomized phase II trial studies how well paclitaxel with or without cixutumumab works in treating patients with esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.

Study Details

Timeline

Phase 2Active
201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2010
Enrollment StartSep 21, 2010
Primary CompletionJul 15, 2014
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.1 years ago

Arms & Interventions

Arm I (paclitaxel)experimental

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

Other: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Pharmacological Study
Arm II (cixutumumab, paclitaxel)experimental

Patients receive cixutumumab IV over 1 hour on days 1 and 15, and paclitaxel as in Arm I.

Biological: CixutumumabOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Pharmacological Study

Interventions

Cixutumumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Pharmacological Studyother

Correlative studies