Trial Outcomes & Findings for Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach (NCT NCT02358863)
NCT ID: NCT02358863
Last Updated: 2018-09-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
1 year
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=13 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearObjective 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.
Outcome measures
| Measure |
Chemotherapy
n=13 Participants
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
|
|---|---|
|
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
|
0 Participants
|
Adverse Events
Chemotherapy
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Chemotherapy
n=13 participants at risk
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
|
|---|---|
|
General disorders
Abdominal Pain
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
15.4%
2/13 • Number of events 2
|
Other adverse events
| Measure |
Chemotherapy
n=13 participants at risk
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
|
|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
7.7%
1/13 • Number of events 1
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
15.4%
2/13 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Edema
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Oral Mucositis
|
7.7%
1/13 • Number of events 2
|
|
Renal and urinary disorders
Urinary Urgency
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Abdominal Pain
|
7.7%
1/13 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • Number of events 1
|
Additional Information
John Marshall, MD
Lombardi Comprehensive Cancer Center (LCCC)
Phone: 202-444-7064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place