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.
Terminated
N/A
| Drug | Synonyms | Arms |
|---|---|---|
| Modified FOLFOX6 | Oxaliplatin, Eloxatin, Leucovorin, 5-FU, 5-Flourouracil | Chemotherapy |
| Docetaxel/Capecitabine | Taxotere, Xeloda | Chemotherapy |
| Cisplatin/Irinotecan | Platinum, CPT-11, Camptosar | Chemotherapy |
| Cisplatin/Docetaxel | Platinum, Taxotere | Chemotherapy |
| IRI/EPI | Irinotecan, CPT-11, Epirubicin, Camptosar | Chemotherapy |
| EPI/Docetaxel | Taxotere, Epirubicin | Chemotherapy |
| Irinotecan/Docetaxel | CPT-11, Camptosar, Taxotere | Chemotherapy |
| Docetaxel | Taxotere | Chemotherapy |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Chemotherapy | Experimental | 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 |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | The Number of Patients With Tumor Size Reduction (Objective Response Rate) |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | 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. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Georgetown University |
September 6, 2018
