A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Modified FOLFOX6
- Conditions
- Esophageal Cancer
- Sponsor
- Georgetown University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- The Number of Patients With Tumor Size Reduction (Objective Response Rate)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Chemotherapy
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
Intervention: Modified FOLFOX6
Chemotherapy
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
Intervention: Docetaxel/Capecitabine
Chemotherapy
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
Intervention: Cisplatin/Irinotecan
Chemotherapy
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
Intervention: Cisplatin/Docetaxel
Chemotherapy
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
Intervention: IRI/EPI
Chemotherapy
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
Intervention: EPI/Docetaxel
Chemotherapy
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
Intervention: Irinotecan/Docetaxel
Chemotherapy
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
Intervention: Docetaxel
Outcomes
Primary Outcomes
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
Time Frame: 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.