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Trial record 28 of 35 for:    pralatrexate AND cells

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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
64.7  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
3
   8.6%
Male
32
  91.4%
1.Primary Outcome
Title Overall Response Rate
Hide 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.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Cohort -1 treated and eligible patients
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26
(12 to 45)
2.Secondary Outcome
Title Number of Participants With an Adverse Event
Hide Description 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
Time Frame Up to 30 days after the last dose of study drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
35
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Estimated using the Kaplan-Meier method and proportional hazards models.
Time Frame From the date of study enrollment to the time of death from any cause, assessed up to 5 years
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Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: months
7.2
(6.4 to 10.8)
4.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Estimated using the Kaplan-Meier method and proportional hazards models.
Time Frame From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: months
5.1
(3.4 to 6.4)
5.Other Pre-specified Outcome
Title Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes
Hide Description Kaplan-Meier estimates of median survival time for each genotype
Time Frame From the date of study enrollment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: months
C Number Analyzed 24 participants
10.22
(6.74 to 12.39)
T Number Analyzed 4 participants
18.71
(2.33 to 31.38)
TC Number Analyzed 7 participants
4.63
(2.30 to 5.45)
6.Other Pre-specified Outcome
Title MicroRNA Expression - miR-215-5p
Hide Description Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling.
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

Overall Number of Participants Analyzed 29
Mean (95% Confidence Interval)
Unit of Measure: Arbitrary fluorescent intensity
Responders: CR+PR
6.6
(5.7 to 7.1)
Non responders: stable disease/progression
5.6
(5.3 to 5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Pralatrexate, Oxaliplatin)
Comments Comparison is CR+PR vs stable disease/progression
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.78 to 1.38
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Pralatrexate, Oxaliplatin)
Hide Arm/Group 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.

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Pralatrexate: Given IV

All-Cause Mortality
Treatment (Pralatrexate, Oxaliplatin)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Pralatrexate, Oxaliplatin)
Affected / at Risk (%) # Events
Total   10/35 (28.57%)    
Cardiac disorders   
Myocardial infarction   1/35 (2.86%)  2
Gastrointestinal disorders   
Gastric haemorrhage   1/35 (2.86%)  2
Stomatitis   1/35 (2.86%)  2
General disorders   
Disease progression   1/35 (2.86%)  2
Pyrexia   1/35 (2.86%)  2
Infections and infestations   
Infection   1/35 (2.86%)  4
Lung infection   1/35 (2.86%)  2
Urinary tract infection   1/35 (2.86%)  2
Investigations   
Haemoglobin   1/35 (2.86%)  4
Metabolism and nutrition disorders   
Dehydration   3/35 (8.57%)  6
Hypokalaemia   1/35 (2.86%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm   1/35 (2.86%)  2
Neoplasm malignant   1/35 (2.86%)  2
Nervous system disorders   
Haemorrhage intracranial   1/35 (2.86%)  2
Respiratory, thoracic and mediastinal disorders   
Aspiration   1/35 (2.86%)  2
Dyspnoea   1/35 (2.86%)  2
Pleural effusion   1/35 (2.86%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Pralatrexate, Oxaliplatin)
Affected / at Risk (%) # Events
Total   35/35 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   9/35 (25.71%)  37
Leukopenia   12/35 (34.29%)  65
Lymphopenia   12/35 (34.29%)  32
Neutropenia   12/35 (34.29%)  42
Thrombocytopenia   10/35 (28.57%)  50
Cardiac disorders   
Tachycardia   3/35 (8.57%)  6
Eye disorders   
Dry eye   1/35 (2.86%)  4
Eye discharge   2/35 (5.71%)  4
Eye pain   1/35 (2.86%)  2
Lacrimation increased   1/35 (2.86%)  2
Vision blurred   2/35 (5.71%)  6
Gastrointestinal disorders   
Abdominal pain   7/35 (20.00%)  16
Abdominal pain lower   1/35 (2.86%)  1
Abdominal pain upper   3/35 (8.57%)  6
Ascites   1/35 (2.86%)  4
Constipation   13/35 (37.14%)  42
Diarrhoea   14/35 (40.00%)  71
Dry mouth   3/35 (8.57%)  6
Dyspepsia   1/35 (2.86%)  2
Dysphagia   6/35 (17.14%)  20
Faecal incontinence   1/35 (2.86%)  2
Flatulence   1/35 (2.86%)  2
Gastrooesophageal reflux disease   1/35 (2.86%)  2
Impaired gastric emptying   1/35 (2.86%)  2
Mouth haemorrhage   1/35 (2.86%)  2
Nausea   22/35 (62.86%)  96
Odynophagia   1/35 (2.86%)  2
Oesophageal stenosis   1/35 (2.86%)  2
Oesophagitis   1/35 (2.86%)  2
Stomatitis   30/35 (85.71%)  169
Vomiting   17/35 (48.57%)  55
General disorders   
Asthenia   1/35 (2.86%)  2
Chest pain   4/35 (11.43%)  8
Chills   1/35 (2.86%)  2
Early satiety   1/35 (2.86%)  2
Fatigue   23/35 (65.71%)  103
Gait disturbance   1/35 (2.86%)  2
Infusion site extravasation   1/35 (2.86%)  2
Localised oedema   1/35 (2.86%)  2
Oedema   1/35 (2.86%)  2
Oedema peripheral   8/35 (22.86%)  25
Pain   1/35 (2.86%)  2
Pyrexia   3/35 (8.57%)  6
Temperature intolerance   3/35 (8.57%)  10
Hepatobiliary disorders   
Hyperbilirubinaemia   2/35 (5.71%)  8
Immune system disorders   
Hypersensitivity   3/35 (8.57%)  6
Infections and infestations   
Abdominal wall infection   1/35 (2.86%)  2
Infection   1/35 (2.86%)  4
Nasopharyngitis   1/35 (2.86%)  2
Oral candidiasis   2/35 (5.71%)  4
Oral infection   1/35 (2.86%)  2
Pneumonia   1/35 (2.86%)  2
Skin infection   1/35 (2.86%)  4
Upper respiratory tract infection   1/35 (2.86%)  2
Injury, poisoning and procedural complications   
Contusion   1/35 (2.86%)  2
Feeding tube complication   1/35 (2.86%)  2
Infusion related reaction   1/35 (2.86%)  2
Road traffic accident   1/35 (2.86%)  2
Thermal burn   1/35 (2.86%)  2
Wound dehiscence   1/35 (2.86%)  2
Investigations   
Alanine aminotransferase increased   2/35 (5.71%)  10
Aspartate aminotransferase   5/35 (14.29%)  16
Aspartate aminotransferase increased   12/35 (34.29%)  40
Blood alkaline phosphatase   6/35 (17.14%)  15
Blood alkaline phosphatase increased   9/35 (25.71%)  27
Blood creatinine   4/35 (11.43%)  10
Blood creatinine increased   2/35 (5.71%)  3
Carbon dioxide increased   1/35 (2.86%)  2
Haemoglobin   12/35 (34.29%)  75
Haemoglobin decreased   9/35 (25.71%)  47
Lymphocyte count decreased   9/35 (25.71%)  49
Neutrophil count decreased   5/35 (14.29%)  13
Platelet count decreased   5/35 (14.29%)  21
Weight decreased   14/35 (40.00%)  42
White blood cell count decreased   6/35 (17.14%)  18
Metabolism and nutrition disorders   
Decreased appetite   9/35 (25.71%)  25
Dehydration   8/35 (22.86%)  16
Hypercalcaemia   2/35 (5.71%)  4
Hyperglycaemia   1/35 (2.86%)  2
Hyperkalaemia   7/35 (20.00%)  21
Hypernatraemia   4/35 (11.43%)  8
Hypoalbuminaemia   18/35 (51.43%)  69
Hypocalcaemia   3/35 (8.57%)  6
Hypoglycaemia   1/35 (2.86%)  2
Hypokalaemia   4/35 (11.43%)  8
Hypomagnesaemia   1/35 (2.86%)  2
Hyponatraemia   8/35 (22.86%)  27
Musculoskeletal and connective tissue disorders   
Arthralgia   1/35 (2.86%)  6
Back pain   5/35 (14.29%)  10
Flank pain   1/35 (2.86%)  2
Joint effusion   1/35 (2.86%)  2
Muscular weakness   5/35 (14.29%)  9
Musculoskeletal pain   1/35 (2.86%)  2
Myalgia   1/35 (2.86%)  4
Neck pain   2/35 (5.71%)  6
Pain in extremity   4/35 (11.43%)  8
Pain in jaw   1/35 (2.86%)  2
Nervous system disorders   
Dizziness   6/35 (17.14%)  16
Dizziness postural   1/35 (2.86%)  2
Dysaesthesia   2/35 (5.71%)  4
Dysgeusia   11/35 (31.43%)  24
Headache   6/35 (17.14%)  11
Neuropathy peripheral   1/35 (2.86%)  2
Paraesthesia   4/35 (11.43%)  22
Peripheral sensory neuropathy   27/35 (77.14%)  106
Peroneal nerve palsy   1/35 (2.86%)  4
Sinus headache   1/35 (2.86%)  2
Psychiatric disorders   
Anxiety   2/35 (5.71%)  6
Confusional state   1/35 (2.86%)  2
Delirium   1/35 (2.86%)  2
Hallucination   1/35 (2.86%)  2
Insomnia   1/35 (2.86%)  4
Restlessness   1/35 (2.86%)  2
Renal and urinary disorders   
Chromaturia   1/35 (2.86%)  2
Dysuria   1/35 (2.86%)  2
Haematuria   1/35 (2.86%)  2
Nephrolithiasis   1/35 (2.86%)  2
Pollakiuria   2/35 (5.71%)  3
Urinary incontinence   1/35 (2.86%)  2
Respiratory, thoracic and mediastinal disorders   
Cough   4/35 (11.43%)  10
Dysphonia   5/35 (14.29%)  14
Dyspnoea   4/35 (11.43%)  8
Dyspnoea exertional   1/35 (2.86%)  2
Epistaxis   12/35 (34.29%)  24
Hiccups   3/35 (8.57%)  6
Hypoxia   1/35 (2.86%)  2
Nasal congestion   2/35 (5.71%)  4
Oropharyngeal pain   1/35 (2.86%)  2
Pleural effusion   1/35 (2.86%)  4
Wheezing   2/35 (5.71%)  4
Skin and subcutaneous tissue disorders   
Alopecia   2/35 (5.71%)  4
Decubitus ulcer   1/35 (2.86%)  2
Dry skin   2/35 (5.71%)  6
Hyperhidrosis   1/35 (2.86%)  2
Night sweats   1/35 (2.86%)  2
Rash   6/35 (17.14%)  12
Rash papular   1/35 (2.86%)  2
Skin hyperpigmentation   1/35 (2.86%)  2
Skin ulcer   1/35 (2.86%)  2
Surgical and medical procedures   
Medical diet   1/35 (2.86%)  2
Vascular disorders   
Deep vein thrombosis   5/35 (14.29%)  10
Embolism   1/35 (2.86%)  2
Hot flush   1/35 (2.86%)  2
Hypertension   1/35 (2.86%)  2
Hypotension   5/35 (14.29%)  10
Orthostatic hypotension   1/35 (2.86%)  2
Superior vena cava syndrome   1/35 (2.86%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
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