Clinical trial · Interventional
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates
NCT01178944CI-TRIAL-00030791completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Esophageal Undifferentiated Carcinoma | Esophageal Undifferentiated Carcinoma | CURATED_BROADER | 0.80 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Squamous Cell Carcinoma | Gastric Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Gastric Carcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Pralatrexate | Drug | Pralatrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (pralatrexate, oxaliplatin)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Oxaliplatin
- Drug: Pralatrexate
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.