Trial Outcomes & Findings for Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma (NCT NCT00390416)
NCT ID: NCT00390416
Last Updated: 2016-03-14
Results Overview
as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
6 months
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not treated
|
3
|
Baseline Characteristics
Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=48 Participants
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsas measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).
Outcome measures
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=39 Participants
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
6 Month Progression Free Survival
|
79 percentage of participants
Interval 63.0 to 88.0
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=39 Participants
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
1-year Survival
Progression Free Survival
|
12 months
Interval 8.8 to 1832.0
|
|
1-year Survival
Overall Survival
|
16.8 months
Interval 12.1 to 26.1
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=39 Participants
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Patients With Measurable Disease the Confirmed Response Rate
Confirmed Response Rate
|
67 percentage of participants
Interval 50.0 to 81.0
|
|
Patients With Measurable Disease the Confirmed Response Rate
Response Rate (proximal/GEJ tumors)
|
85 percentage of participants
Interval 62.0 to 97.0
|
Adverse Events
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Serious events: 27 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=48 participants at risk
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Investigations
White blood cell decreased
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis-Oral
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
8.3%
4/48 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
16.7%
8/48 • Number of events 9
|
|
Gastrointestinal disorders
Rectal obstruction
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
4/48 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
2/48 • Number of events 3
|
|
Cardiac disorders
Chest pain-cardiac
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal perforation
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Gastric perforation
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Platelet count decrease
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.3%
4/48 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
3/48 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Bilirubin increased
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
6.2%
3/48 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
6/48 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/48 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Fatigue
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
2/48 • Number of events 2
|
|
Gastrointestinal disorders
Anal fistula
|
2.1%
1/48 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, Abdomen NOS
|
2.1%
1/48 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.2%
2/48 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Infection, other
|
6.2%
3/48 • Number of events 4
|
Other adverse events
| Measure |
Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
n=48 participants at risk
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
|---|---|
|
Investigations
Alanine aminotransferase increase
|
8.3%
4/48 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increase
|
10.4%
5/48 • Number of events 9
|
|
Immune system disorders
Allergic reaction
|
12.5%
6/48 • Number of events 8
|
|
Metabolism and nutrition disorders
Anorexia
|
10.4%
5/48 • Number of events 7
|
|
Investigations
Creatinine increased
|
8.3%
4/48 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
8/48 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhea
|
27.1%
13/48 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
4/48 • Number of events 6
|
|
General disorders
Fatigue
|
58.3%
28/48 • Number of events 104
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
6.2%
3/48 • Number of events 18
|
|
Blood and lymphatic system disorders
Anemia
|
54.2%
26/48 • Number of events 241
|
|
Investigations
White blood cell decreased
|
75.0%
36/48 • Number of events 197
|
|
Investigations
Lymphocyte count decreased
|
54.2%
26/48 • Number of events 115
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.7%
20/48 • Number of events 112
|
|
Gastrointestinal disorders
Mucositis-Oral
|
41.7%
20/48 • Number of events 37
|
|
Gastrointestinal disorders
Nausea
|
25.0%
12/48 • Number of events 24
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
16/48 • Number of events 54
|
|
Investigations
Neutrophil count decreased
|
70.8%
34/48 • Number of events 127
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
3/48 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
62.5%
30/48 • Number of events 119
|
|
Investigations
Platelet count decreased
|
22.9%
11/48 • Number of events 58
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
4/48 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.2%
3/48 • Number of events 6
|
|
Nervous system disorders
Dysgeusia
|
8.3%
4/48 • Number of events 4
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
39.6%
19/48 • Number of events 21
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
4/48 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
5/48 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place