Trial Outcomes & Findings for Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer (NCT NCT00683787)
NCT ID: NCT00683787
Last Updated: 2015-01-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
1 year
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
Arm A: Docetaxel
Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks
|
Arm B: Docetaxel+VANDETANIB (100 mg)
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Arm C: Docetaxel+VANDETANIB (300 mg)
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
Arm A: Docetaxel
Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks
|
Arm B: Docetaxel+VANDETANIB (100 mg)
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Arm C: Docetaxel+VANDETANIB (300 mg)
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
|---|---|---|---|
|
Overall Study
Progression
|
3
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Docetaxel
n=3 Participants
Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks
|
Arm B: Docetaxel+VANDETANIB (100 mg)
n=3 Participants
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Arm C: Docetaxel+VANDETANIB (300 mg)
n=2 Participants
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.67 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
67 years
STANDARD_DEVIATION 3.61 • n=7 Participants
|
60 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
61.38 years
STANDARD_DEVIATION 7.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Docetaxel
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B: Docetaxel+VANDETANIB (100 mg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: Docetaxel+VANDETANIB (300 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Docetaxel
n=3 participants at risk
Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks
|
Arm B: Docetaxel+VANDETANIB (100 mg)
n=3 participants at risk
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Arm C: Docetaxel+VANDETANIB (300 mg)
n=2 participants at risk
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Arm A: Docetaxel
n=3 participants at risk
Patients receive docetaxel IV once every 3 weeks.
docetaxel: Given IV once every 3 weeks
|
Arm B: Docetaxel+VANDETANIB (100 mg)
n=3 participants at risk
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
Arm C: Docetaxel+VANDETANIB (300 mg)
n=2 participants at risk
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
docetaxel: Given IV once every 3 weeks
vandetanib: Oral vandetanib once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 4
|
0.00%
0/3
|
100.0%
2/2 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 7
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 7
|
66.7%
2/3 • Number of events 3
|
100.0%
2/2 • Number of events 5
|
|
General disorders
Mucosal inflammation
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
0.00%
0/2
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
100.0%
2/2 • Number of events 3
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Investigations
Blood alkaline phosphatase
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Investigations
Blood creatine increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Investigations
Blood creatinine
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/2
|
|
Investigations
Electrocardiogram QT corrected interval
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 3
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Investigations
Haemoglobin
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Investigations
International normalised ratio
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Investigations
Neutrophil count
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
50.0%
1/2 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
3/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
3/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
|
33.3%
1/3 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
66.7%
2/3 • Number of events 6
|
0.00%
0/3
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place