We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129206
First Posted: May 24, 2010
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Comprehensive Cancer Network
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Esophagus Adenocarcinomas of the Gastroesophageal Junction Recurrent Esophageal Cancer Squamous Cell Carcinoma of the Esophagus Stage IV Esophageal Cancer Drug: pralatrexate Drug: docetaxel Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.

Resource links provided by NLM:


Further study details as provided by Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response [ Time Frame: Approximately three years ]
    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


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Approximately three years ]
    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

  • Overall Survival (OS) [ Time Frame: Approximately five years ]
    OS was determined from the date of start of therapy to death frm any cause.

  • Correlation of FDG PET Response With Response Rate [ Time Frame: Approximately three years ]
    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.


Enrollment: 6
Study Start Date: July 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
Other Names:
  • FOLOTYN
  • PDX
Drug: 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.
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Radiation: fludeoxyglucose F 18
Correlative studies
Other Names:
  • 18FDG
  • FDG
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • fluorodeoxyglucose F 18
Procedure: positron emission tomography
Correlative studies
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • 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
  • Hepatic: Serum bilirubin < 1.5 x ULN(upper limit of normal) and AST (aspartate aminotransferase) and ALT (Alanine aminotransferase)=< 2.5 x ULN
  • Prior minor surgeries (such as laparoscopies) must have occurred at least 14 days prior to study enrollment; prior minor procedures such as biopsies and mediport placement must have occurred at least 48 hours prior to study enrollment
  • All patients must have signed an informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
  • History of allergic reactions attributed to compounds of similar chemical composition to agents used in the study

Exclusion

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129206


Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Comprehensive Cancer Network
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Tony Saab, MD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Tony Bekaii-Saab, Principal Investigator, 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
Last Verified: April 2016

Keywords provided by Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center:
Gastroesophageal Cancer
Gastroesophageal Carcinoma
Adenocarcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Fluorodeoxyglucose F18
Aminopterin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Folic Acid Antagonists
Enzyme Inhibitors