Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
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|ClinicalTrials.gov Identifier: NCT01178944|
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Drug: Oxaliplatin Drug: Pralatrexate||Phase 2|
I. To determine the overall response rate in patients with advanced esophago-gastric cancer (EGC) to combination pralatrexate and oxaliplatin.
I. To examine the toxicity and tolerability of this regimen. II. To determine the time-to-progression and overall survival using this regimen.
III. To examine whether functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with efficacy and toxicity of pralatrexate.
IV. To examine whether response to pralatrexate can be predicted by micro-ribonucleic acid (microRNA) expression profiling of the epithelial component of the tumor.
Patients receive pralatrexate intravenously (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.
After completion of study treatment, patients are followed up for 30 days and then periodically thereafter for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||November 2015|
Experimental: 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.
Other: Laboratory Biomarker Analysis
- Overall Response Rate [ Time Frame: Up to 5 years ]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 Response (OR) = CR + PR.
- Number of Participants With an Adverse Event [ Time Frame: Up to 30 days after the last dose of study drug(s) ]Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- Overall Survival (OS) [ Time Frame: From the date of study enrollment to the time of death from any cause, assessed up to 5 years ]Estimated using the Kaplan-Meier method and proportional hazards models.
- Time to Progression (TTP) [ Time Frame: From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years ]Estimated using the Kaplan-Meier method and proportional hazards models.
- Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes [ Time Frame: From the date of study enrollment up to 5 years ]Kaplan-Meier estimates of median survival time for each genotype
- MicroRNA Expression - miR-215-5p [ Time Frame: Baseline ]Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178944
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Rochester General Hospital|
|Rochester, New York, United States, 14621|
|Principal Investigator:||Nikhil Khushalani||Roswell Park Cancer Institute|