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
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Condition or disease | Intervention/treatment | Phase |
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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 |
PRIMARY OBJECTIVES:
I. To determine the overall response rate in patients with advanced esophago-gastric cancer (EGC) to combination pralatrexate and oxaliplatin.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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.
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Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Oxaliplatin
Given IV
Other Names:
Drug: Pralatrexate
Given IV
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed carcinoma of the esophagus, stomach or gastro-esophageal junction that is metastatic, or locally advanced and inoperable for cure; histological sub-types permitted include adenocarcinoma, squamous-cell carcinoma, or undifferentiated carcinoma; small-cell carcinoma variant is not eligible
- No previous systemic therapy for metastatic or recurrent disease; therapy (chemotherapy, radiotherapy, or both) administered in the neo-adjuvant, adjuvant, or definitive setting for previously localized disease is permitted, provided it was completed more than 6 months prior to enrollment; palliative radiotherapy is permitted provided it is completed >= 3 weeks prior to study therapy initiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >= 12 weeks
- Hemoglobin >= 9 g/dl
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Serum creatinine =< institutional upper limit normal (ULN)
- Bilirubin =< 1.5 x ULN
- Transaminases =< 3 x ULN; for documented liver metastases, transaminases up to 5 x ULN is permitted
- No evidence of >= grade 2 peripheral neuropathy
- Patients with reproductive potential must be willing to use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment; a negative pregnancy test is required for women of child-bearing potential; nursing women are ineligible
- Written, informed consent
Exclusion Criteria:
- Hypersensitivity to platinum compounds
- Uncontrolled inter-current illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
- Presence of brain metastases
- Patients with third-space (pleural, peritoneal) fluid not controllable with usual drainage methods are not eligible
- History of second primary malignancy within 3 years prior to enrollment, except for in-situ cervix carcinoma or non-melanoma skin cancer
- Undergone an allogeneic stem cell transplant

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 |
Documents provided by Roswell Park Cancer Institute:
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 Posted: | August 10, 2010 Key Record Dates |
Results First Posted: | December 13, 2017 |
Last Update Posted: | December 13, 2017 |
Last Verified: | November 2017 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Stomach Neoplasms Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Head and Neck Neoplasms Esophageal Diseases Oxaliplatin 10-deazaaminopterin Aminopterin Antineoplastic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |