Esophageal Cancer, Gastric Cancer
Conditions
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.
Interventions
DRUGModified FOLFOX6
Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1
Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
DRUGCisplatin/Irinotecan
Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days
Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
DRUGIRI/EPI
Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days
DRUGEPI/Docetaxel
Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
DRUGIrinotecan/Docetaxel
Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1
DRUGDocetaxel
Docetaxel 60-100 mg/m2 IV day 1 every 21 days
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Modified FOLFOX6: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1
Docetaxel/Capecitabine: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
Cisplatin/Irinotecan: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days
Cisplatin/Docetaxel: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
IRI/EPI: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days
EPI/Docetaxel: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
Irinotecan/Docetaxel: Irinote | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 13 |
| other Total, other adverse events | 3 / 13 |
| serious Total, serious adverse events | 3 / 13 |
Outcome results
Primary
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | The Number of Patients With Tumor Size Reduction (Objective Response Rate) | 0 Participants |