Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy

Stopped early · Phase 2

Conditions studied: Stage IB Esophageal Adenocarcinoma, Stage IIA Esophageal Adenocarcinoma, Stage IIB Esophageal Adenocarcinoma, Stage IIIA Esophageal Adenocarcinoma, Stage IIIB Esophageal Adenocarcinoma, Stage IIIC Esophageal Adenocarcinoma

In brief

This randomized pilot phase II trial studies how well molecular phenotyping works in predicting response in patients with stage IB-III esophageal cancer who are receiving carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the genes in a patients tumor cells before and after chemotherapy may help in understanding if there are specific features of the tumor cells that make a person more or less likely to respond to treatment and how these features may be affected by treatment.

Key facts

Study ID: NCT02392377
Run by: Case Comprehensive Cancer Center
People needed: 1
Starts: 2015-02-01
Expected to finish: 2015-12-01
Last updated by the study team: 2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed localized (T1N1-3M0 or T2-4NanyM0, stage IB-III) Siewert type 1 or type 2 esophageal adenocarcinoma that is amenable to surgical resection as determined by a thoracic surgeon and for which all disease (primary tumor and involved lymph nodes) can be treated with radiation, as determined by a radiation oncologist
Patients may not have received any prior chemotherapy, biologic therapy or radiation therapy for management of their disease; chemotherapy or biologic therapy administered for treatment of another primary malignancy are permitted if treatment was greater than 5 years ago
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients must have a life expectancy of > 3 months, in the opinion of and as documented by the investigator
Hemoglobin >= 10.0 g/dl
Absolute neutrophil count >= 1,500/mcL
Platelet count >= 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 X institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
Serum creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (as calculated by Cockcroft-Gault)
Patients must have an avid primary tumor with an standardized uptake value (SUV) of >= 5 on baseline (18F) FDG-PET/computed tomography (CT) imaging
Men must agree to use adequate contraception (double barrier method of birth control or abstinence) 1 week prior to study entry, for the duration of study participation and for 1 month after completing combined modality treatment with chemotherapy and radiation; should a male patient's female partner become pregnant or suspect that she is pregnant while her partner is participating in this study, the treating physician should be informed immediately
Patients must have the ability to understand and the willingness to sign a written informed consent document
This study will be limited to enrollment of Caucasian males only

You may not qualify if…

Patients who are receiving any chemotherapy, biologic therapy, radiation therapy or any investigational agent
Patients with metastatic disease
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to platinums, taxanes or fluoropyrimidines
Patients who have previously received radiation therapy to the chest or abdomen such that there would be overlap between the previous and current radiation field
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with human immunodeficiency virus (HIV) whom are not receiving antiretroviral therapy
Patients with another malignancy within the past 5 years

Where it is running

Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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