MedTrace Logo

Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

NCT01142388 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-04-29

Study results available
· View outcomes & findings →

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.

Conditions

  • Metastatic Esophageal Adenocarcinoma
  • Metastatic Esophageal Squamous Cell Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Recurrent Esophageal Adenocarcinoma
  • Recurrent Esophageal Carcinoma
  • Recurrent Esophageal Squamous Cell Carcinoma
  • Recurrent Gastroesophageal Junction Adenocarcinoma
  • Stage IV Esophageal Cancer AJCC v7

Interventions

BIOLOGICAL

Cixutumumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven J Cohen · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-21
Primary Completion
2014-07-15
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142388 on ClinicalTrials.gov