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NCT01142388 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
A Phase 2 study of Metastatic Gastroesophageal Junction Adenocarcinoma and Metastatic Esophageal Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT01142388: Active Phase 2 study of Metastatic Gastroesophageal Junction Adenocarcinoma and Metastatic Esophageal Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01142388 is a Phase 2 study of Metastatic Gastroesophageal Junction Adenocarcinoma and Metastatic Esophageal Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 94 participants, above the 30-participant average among 8 other Metastatic Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (213% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01142388, a Phase 2 study of Metastatic Gastroesophageal Junction Adenocarcinoma and Metastatic Esophageal Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of dis
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2010-09-21 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT01142388 still lists
NCT01142388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 30-participant average among 8 other Metastatic Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (213% higher).
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.
NCT01142388 names 20 study sites across 3 states, led by Colorado, Arizona, California.
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.
What interventions are being tested in trial NCT01142388?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01142388?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Metastatic Gastroesophageal Junction Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01142388's enrollment target sits among peer trials
94 1st of 8 higher than 8 of 8 other Metastatic Gastroesophageal Junction Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Gastroesophageal Junction Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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