Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

Not Applicable

Terminated

• Conditions: Esophageal Cancer; Gastric Cancer
• Interventions: Drug: Modified FOLFOX6; Drug: Docetaxel/Capecitabine; Drug: Cisplatin/Irinotecan; Drug: Cisplatin/Docetaxel; Drug: IRI/EPI; Drug: EPI/Docetaxel; Drug: Irinotecan/Docetaxel; Drug: Docetaxel

• Registration Number: NCT02358863
• Lead Sponsor: Georgetown University

Brief Summary

The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-09
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-08
• Results First Submitted: 2018-05-02
• Results First Submitted QC: 2018-05-02
• Results First Posted: 2018-06-04
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
• Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
• Patients who are not eligible for resection and are chemotherapy naïve
• Patients with HER2(-) status
• Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
• Patients must have adequate organ function
• Patients must provide written informed consent

Exclusion Criteria

• Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
• ECOG performance status worse than 2
• Prior oral or intravenous chemotherapy for metastatic disease
• Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
• cardiac ejection fraction 45% or greater

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Modified FOLFOX6	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	IRI/EPI	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	Docetaxel	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	Docetaxel/Capecitabine	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	Cisplatin/Irinotecan	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	Cisplatin/Docetaxel	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	EPI/Docetaxel	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Chemotherapy	Irinotecan/Docetaxel	Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel

Primary Outcome Measures

Name	Time	Method
The Number of Patients With Tumor Size Reduction (Objective Response Rate)	1 year	Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States