Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedResults Posted
Study results publicly available
October 16, 2015
CompletedJune 1, 2016
April 1, 2016
2.2 years
May 21, 2010
September 15, 2015
April 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Approximately three years
Secondary Outcomes (3)
Progression-free Survival (PFS)
Approximately three years
Overall Survival (OS)
Approximately five years
Correlation of FDG PET Response With Response Rate
Approximately three years
Study Arms (1)
Arm I
EXPERIMENTALPatients 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.
Interventions
IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
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.
Correlative studies
Correlative studies
Eligibility Criteria
You may qualify if:
- Pathologically confirmed unresectable advanced or metastatic carcinoma of the esophagus or gastroesophageal junction
- Established histological confirmation of squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- Stage IV disease
- Must have received platinum-based therapy; this includes definitive, adjuvant and metastatic treatments
- No more than 3 chemotherapeutic treatment regimens permitted; this includes concurrent chemoradiation
- Radiation therapy allowed if \> 4 weeks have elapsed
- Must be off therapy for 4 weeks prior to enrollment
- Measurable disease as defined by RECIST v 1.1 criteria
- ECOG (Eastern Cooperative Oncology Group)PS(Performance status)of 0 to 2
- Predicted life expectancy of at least 12 weeks
- Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial and for three months after completion of treatment
- Marrow: ANC(absolute neutrophil count)\> 1,000/mm\^3
- Marrow: Hemoglobin \> 9.0 g/dl
- Marrow: Platelet Count \> 100,000/mm\^3
- Renal: Serum creatinine =\< 1.5 g/dL
- +4 more criteria
You may not qualify if:
- Pregnant or lactating women
- Patients with any severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry
- Any malignant condition for which one has received treatment in the last two years excluding squamous or basal cell carcinomas
- Patients with untreated brain metastases
- Patients must not have grade 2 or higher baseline peripheral neuropathy, according to CTCAE v 4.0
- Patients must have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures; all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE v 4.0) Grade =\< 1 prior to study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University
Columbus, Ohio, 43210, United States
Related Publications (1)
Petullo B, Wei L, Yereb M, Neal A, Rose J, Bekaii-Saab T, Wu C. A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy. J Gastrointest Oncol. 2015 Jun;6(3):336-40. doi: 10.3978/j.issn.2078-6891.2015.011.
PMID: 26029462BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tanios Bekaii Saab, MD
- Organization
- The Ohio State University Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Saab, MD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2012
Last Updated
June 1, 2016
Results First Posted
October 16, 2015
Record last verified: 2016-04