Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:27 PM
Study NCT ID:
NCT01129206
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2010-05-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.
PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate overall response rate CR \& PR(Complete Response + Partial Response)as assessed by RECIST (Response Evaluation Criteria in Solid Tumors v 1.1) of the combination of pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinomas.
SECONDARY OBJECTIVES:
I. Evaluation of progression free survival and overall survival. II. Correlation of FDG(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in SUV(standard uptake value)during the early course of chemotherapy to progression free and overall survival in addition to radiographic response as measured by RECIST v 1.1 criteria on CT imaging.
OUTLINE:
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.
I. To evaluate overall response rate CR \& PR(Complete Response + Partial Response)as assessed by RECIST (Response Evaluation Criteria in Solid Tumors v 1.1) of the combination of pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinomas.
SECONDARY OBJECTIVES:
I. Evaluation of progression free survival and overall survival. II. Correlation of FDG(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in SUV(standard uptake value)during the early course of chemotherapy to progression free and overall survival in addition to radiographic response as measured by RECIST v 1.1 criteria on CT imaging.
OUTLINE:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2010-01225 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |