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Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178944
First Posted: August 10, 2010
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Results First Submitted: July 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Undifferentiated Carcinoma
Gastric Adenocarcinoma
Gastric Squamous Cell Carcinoma
Recurrent Esophageal Adenocarcinoma
Recurrent Esophageal Squamous Cell Carcinoma
Recurrent Gastric Carcinoma
Stage IIIB Esophageal Adenocarcinoma
Stage IIIB Esophageal Squamous Cell Carcinoma
Stage IIIB Gastric Cancer
Stage IIIC Esophageal Adenocarcinoma
Stage IIIC Esophageal Squamous Cell Carcinoma
Stage IIIC Gastric Cancer
Stage IV Esophageal Adenocarcinoma
Stage IV Esophageal Squamous Cell Carcinoma
Stage IV Gastric Cancer
Undifferentiated Gastric Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Oxaliplatin
Drug: Pralatrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Pralatrexate, Oxaliplatin)

Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV


Participant Flow:   Overall Study
    Treatment (Pralatrexate, Oxaliplatin)
STARTED   35 
COMPLETED   35 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
Treatment (Pralatrexate, Oxaliplatin)

Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV


Baseline Measures
   Treatment (Pralatrexate, Oxaliplatin) 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3   8.6% 
Male      32  91.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Up to 5 years ]

2.  Secondary:   Number of Participants With an Adverse Event   [ Time Frame: Up to 30 days after the last dose of study drug(s) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of study enrollment to the time of death from any cause, assessed up to 5 years ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years ]

5.  Other Pre-specified:   Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes   [ Time Frame: From the date of study enrollment up to 5 years ]

6.  Other Pre-specified:   MicroRNA Expression - miR-215-5p   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01178944     History of Changes
Other Study ID Numbers: I 169210
NCI-2010-01583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 169210 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2010
First Posted: August 10, 2010
Results First Submitted: July 19, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017