Trial · NCT01178944
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
NCT01178944, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2017-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer. Trials, record NCT01178944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01178944
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
- NCT number
- NCT01178944
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- 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
- Laboratory Biomarker Analysis, Oxaliplatin, Pralatrexate
- First posted
- 2010-08-10
- Last updated
- 2017-12-13
- Results first posted
- 2017-12-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 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. |
| Secondary | Number of Participants With an Adverse Event | 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 |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Time to Progression (TTP) | 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. |
| Other | Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | From the date of study enrollment up to 5 years | Kaplan-Meier estimates of median survival time for each genotype |
| Other | MicroRNA Expression - miR-215-5p | Baseline | Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Up to 5 years | All Cohort -1 treated and eligible patients | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Adverse Event | Up to 30 days after the last dose of study drug(s) | All treated and eligible patients | participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From the date of study enrollment to the time of death from any cause, assessed up to 5 years | All treated and eligible patients. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years | All treated and eligible patients | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | From the date of study enrollment up to 5 years | All treated and eligible patients | months | MEDIAN |
| OTHER_PRE_SPECIFIED | MicroRNA Expression - miR-215-5p | Baseline | All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling. | Arbitrary fluorescent intensity | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Treatment (Pralatrexate, Oxaliplatin) | 26 | 95% Confidence Interval 12 to 45 | percentage of participants | |
| Number of Participants With an Adverse Event | Treatment (Pralatrexate, Oxaliplatin) | 35 | participants | ||
| Overall Survival (OS) | Treatment (Pralatrexate, Oxaliplatin) | 7.2 | 95% Confidence Interval 6.4 to 10.8 | months | |
| Time to Progression (TTP) | Treatment (Pralatrexate, Oxaliplatin) | 5.1 | 95% Confidence Interval 3.4 to 6.4 | months | |
| Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | Treatment (Pralatrexate, Oxaliplatin) | C | 10.22 | 95% Confidence Interval 6.74 to 12.39 | months |
| Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | Treatment (Pralatrexate, Oxaliplatin) | T | 18.71 | 95% Confidence Interval 2.33 to 31.38 | months |
| Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes | Treatment (Pralatrexate, Oxaliplatin) | TC | 4.63 | 95% Confidence Interval 2.30 to 5.45 | months |
| MicroRNA Expression - miR-215-5p | Treatment (Pralatrexate, Oxaliplatin) | Responders: CR+PR | 6.6 | 95% Confidence Interval 5.7 to 7.1 | Arbitrary fluorescent intensity |
| MicroRNA Expression - miR-215-5p | Treatment (Pralatrexate, Oxaliplatin) | Non responders: stable disease/progression | 5.6 | 95% Confidence Interval 5.3 to 5.9 | Arbitrary fluorescent intensity |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pralatrexate, Oxaliplatin) | 35 | |
| Overall Study | COMPLETED | Treatment (Pralatrexate, Oxaliplatin) | 35 | |
| Overall Study | NOT COMPLETED | Treatment (Pralatrexate, Oxaliplatin) | 0 |
Source ClinicalTrials.gov
Adverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Treatment (Pralatrexate, Oxaliplatin) | 9 | 35 | 37 |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment (Pralatrexate, Oxaliplatin) | 12 | 35 | 65 |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment (Pralatrexate, Oxaliplatin) | 12 | 35 | 32 |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment (Pralatrexate, Oxaliplatin) | 12 | 35 | 42 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Pralatrexate, Oxaliplatin) | 10 | 35 | 50 |
| other | Tachycardia | Cardiac disorders | Treatment (Pralatrexate, Oxaliplatin) | 3 | 35 | 6 |
| other | Dry eye | Eye disorders | Treatment (Pralatrexate, Oxaliplatin) | 1 | 35 | 4 |
| other | Eye discharge | Eye disorders | Treatment (Pralatrexate, Oxaliplatin) | 2 | 35 | 4 |
| other | Eye pain | Eye disorders | Treatment (Pralatrexate, Oxaliplatin) | 1 | 35 | 2 |
| other | Lacrimation increased | Eye disorders | Treatment (Pralatrexate, Oxaliplatin) | 1 | 35 | 2 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pralatrexate, Oxaliplatin) | ||
| Total, other adverse events | Treatment (Pralatrexate, Oxaliplatin) | 35 | 35 |
| Total, serious adverse events | Treatment (Pralatrexate, Oxaliplatin) | 10 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01178944
GET https://conductscience.org/api/trials/v1/NCT01178944/events?page=2