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ACTIVE NOT RECRUITING Phase 2

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

NCT01142388 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Paclitaxel
  • OTHER Pharmacological Study
  • BIOLOGICAL Cixutumumab

Study Locations (20)

Colorado

  • The Medical Center of Aurora — Aurora
  • Boulder Community Foothills Hospital — Boulder
  • Penrose-Saint Francis Healthcare — Colorado Springs
  • AdventHealth Porter — Denver
  • Presbyterian - Saint Lukes Medical Center - Health One — Denver
  • Saint Joseph Hospital - Cancer Centers of Colorado — Denver
  • Rose Medical Center — Denver
  • Western States Cancer Research NCORP — Denver
  • Swedish Medical Center — Englewood
  • Saint Mary's Hospital and Regional Medical Center — Grand Junction
  • Banner North Colorado Medical Center — Greeley
  • Saint Anthony Hospital — Lakewood
  • AdventHealth Littleton — Littleton
  • Sky Ridge Medical Center — Lone Tree
  • Longmont United Hospital — Longmont
  • Banner North Colorado Medical Center - Loveland Campus — Loveland
  • AdventHealth Parker — Parker
  • Saint Mary Corwin Medical Center — Pueblo

Arizona

  • Mayo Clinic in Arizona — Scottsdale

California

  • Stanford Cancer Institute Palo Alto — Palo Alto

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2010-09-21
Est. Completion 2026-03-19
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01142388

The ClinicalTrials.gov registry entry for NCT01142388 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Metastatic Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01142388 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01142388 about?

NCT01142388 is a clinical study titled "Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer". 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 way...

What is the current status of trial NCT01142388?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2010-09-21. Estimated completion is 2026-03-19.

What conditions does trial NCT01142388 study?

This clinical trial studies the following conditions: Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Esophageal Adenocarcinoma, Stage IV Esophageal Cancer AJCC v7, Metastatic Esophageal Squamous Cell Carcinoma, Recurrent Esophageal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01142388?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER), Cixutumumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01142388?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01142388 being conducted?

This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial