Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01178944 · ClinicalTrials.gov registry record · Phase 2
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
A Phase 2 study of Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT01178944: Completed Phase 2 study of Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction, sponsored by Roswell Park Cancer Institute.
NCT01178944 is a Phase 2 study of Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 35 participants, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178944, a Phase 2 study of Gastric Adenocarcinoma and Adenocarcinoma of the Gastroesophageal Junction, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, 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. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.
Primary Outcome
Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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 Re
Conditions Studied
Interventions
- DRUG Oxaliplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Pralatrexate
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
- Rochester General Hospital - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT01178944 record still lists
NCT01178944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Oxaliplatin is the first listed.
NCT01178944 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01178944 about?
NCT01178944 is a clinical study titled "Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer". This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop ...
What is the current status of trial NCT01178944?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2010-09. Estimated completion is 2015-11.
What conditions does trial NCT01178944 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Stage IIIB Gastric Cancer, Stage IIIB Esophageal Adenocarcinoma, Gastric Squamous Cell Carcinoma.
What interventions are being tested in trial NCT01178944?
The interventions under investigation include: Oxaliplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Pralatrexate (DRUG).
Who is sponsoring clinical trial NCT01178944?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01178944 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastric 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 NCT01178944's enrollment target sits among peer trials
35 35th of 47 higher than 13 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric 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
-
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
RECRUITING · Phase 2
-
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
RECRUITING · Phase 2
-
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
RECRUITING · Phase 2
-
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
RECRUITING · Phase 2
-
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
RECRUITING · Phase 2
-
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia