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NCT01129206 · ClinicalTrials.gov registry record · Phase 2
Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
A Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01129206: Completed Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT01129206 is a Phase 2 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129206, a Phase 2 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Interventions
- DRUG docetaxel
- RADIATION fludeoxyglucose F 18
- PROCEDURE positron emission tomography
- DRUG pralatrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-07 |
| Phase | Phase 2 |
What the finished NCT01129206 record still lists
NCT01129206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which docetaxel is the first listed.
NCT01129206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01129206 about?
NCT01129206 is a clinical study titled "Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy". 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 pralatrexa...
What is the current status of trial NCT01129206?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2010-07.
What interventions are being tested in trial NCT01129206?
The interventions under investigation include: docetaxel (DRUG), fludeoxyglucose F 18 (RADIATION), positron emission tomography (PROCEDURE), pralatrexate (DRUG).
Who is sponsoring clinical trial NCT01129206?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01129206's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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