A Phase 2 interventional study of pralatrexate and docetaxel in Adenocarcinoma of the Esophagus, Adenocarcinomas of the Gastroesophageal Junction and Recurrent Esophageal Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 72 are open to participants now.
This study's enrollment of 6 is below the median of 74 across 110 interventional studies indexed under Adenocarcinoma Of Esophagus.
Browse Adenocarcinoma Of Esophagus studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Exclusion
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.
Drug: pralatrexate · Drug: docetaxel · Radiation: fludeoxyglucose F 18 · Procedure: positron emission tomography
IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
Also known as: FOLOTYN, PDX
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.
Also known as: RP 56976, Taxotere, TXT
Correlative studies
Also known as: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18
Correlative studies
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Overall Response
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
Progression-free Survival (PFS)
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
Overall Survival (OS)
OS was determined from the date of start of therapy to death frm any cause.
Time frame: Approximately five years
Correlation of FDG PET Response With Response Rate
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
This was a phase II single-arm, open label trial performed at The Ohio State University James Cancer Hospital.
| Milestone | Arm I: Pralatrexate and Docetaxel |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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
| patients | Arm I: Pralatrexate and Docetaxel |
|---|---|
| Stable disease | 2 |
| Progressive disease | 4 |
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
| months | Arm I: Pralatrexate and Docetaxel |
|---|---|
| Progression-free Survival (PFS) | 1.9 (0.8 to 7.2) |
OS was determined from the date of start of therapy to death frm any cause.
| months | Arm I |
|---|---|
| Overall Survival (OS) | 5.5 (0.8 to 11.7) |
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.
| patients | PERCIST Criteria Per PET | RECIST Criteria Per CT |
|---|---|---|
| Progressive Disease | 0 | 4 |
| Stable Disease | 2 | 2 |
| Partial Response | 2 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 0/6 (0%) | 6/6 (100%) |
| Event | Arm I |
|---|---|
| LymphopeniaInvestigations | 6/6 |
| AnemiaBlood and lymphatic system disorders | 2/6 |
| LeukopeniaInvestigations | 2/6 |
| MucocitisGastrointestinal disorders | 2/6 |
| Age, Continuous(years) | Arm I |
|---|---|
| Median | 63.5 (55 to 73) |
| Sex: Female, Male(Participants) | Arm I |
|---|---|
| Female | 1 |
| Male | 5 |
| Region of Enrollment(participants) | Arm I |
|---|---|
| United States | 6 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pralatrexate · Docetaxel
Ohio State University Comprehensive Cancer Center →