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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01129206 |
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Date of registration:
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21/05/2010 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy. |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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32 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01129206 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeffrey Rose |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Key inclusion & exclusion criteria
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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 PS 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 > 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 and AST and ALT =< 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adenocarcinoma of the Esophagus
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Adenocarcinomas of the Gastroesophageal Junction
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Recurrent Esophageal Cancer
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Squamous Cell Carcinoma of the Esophagus
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Stage IV Esophageal Cancer
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Intervention(s)
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Drug: docetaxel
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Drug: pralatrexate
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Procedure: positron emission tomography
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Radiation: fludeoxyglucose F 18
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Primary Outcome(s)
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Overall response
[Time Frame: Approximately three years]
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Secondary Outcome(s)
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Correlation of FDG PET response with response rate
[Time Frame: Approximately three years]
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Overall survival
[Time Frame: Approximately five years]
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Progression-free survival
[Time Frame: Approximately three years]
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Secondary ID(s)
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NCI-2010-01225
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OSU-10018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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