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Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

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ClinicalTrials.gov Identifier: NCT01129206
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : October 16, 2015
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Esophagus
Adenocarcinomas of the Gastroesophageal Junction
Recurrent Esophageal Cancer
Squamous Cell Carcinoma of the Esophagus
Stage IV Esophageal Cancer
Interventions Drug: pralatrexate
Drug: docetaxel
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Enrollment 6
Recruitment Details This was a phase II single-arm, open label trial performed at The Ohio State University James Cancer Hospital.
Pre-assignment Details  
Arm/Group Title Arm I: Pralatrexate and Docetaxel
Hide Arm/Group Description

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
63.5
(55 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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 Approximately three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I: Pralatrexate and Docetaxel
Hide Arm/Group Description:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: patients
Stable disease 2
Progressive disease 4
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Approximately three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I: Pralatrexate and Docetaxel
Hide Arm/Group Description:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(0.8 to 7.2)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was determined from the date of start of therapy to death frm any cause.
Time Frame Approximately five years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(0.8 to 11.7)
4.Secondary Outcome
Title Correlation of FDG PET Response With Response Rate
Hide Description Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.
Time Frame Approximately three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 patients not evaluable for response applying the PERCIST criteria per PET
Arm/Group Title PERCIST Criteria Per PET RECIST Criteria Per CT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 4 6
Measure Type: Number
Unit of Measure: patients
Progressive Disease 0 4
Stable Disease 2 2
Partial Response 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/6 (33.33%)  2
Gastrointestinal disorders   
Mucocitis  1  2/6 (33.33%)  2
Investigations   
Lymphopenia  1  6/6 (100.00%)  6
Leukopenia  1  2/6 (33.33%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Tanios Bekaii Saab, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6529
Responsible Party: Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01129206     History of Changes
Other Study ID Numbers: OSU-10018
NCI-2010-01225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: September 15, 2015
Results First Posted: October 16, 2015
Last Update Posted: June 1, 2016