Trial Outcomes & Findings for Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer (NCT NCT01267240)
NCT ID: NCT01267240
Last Updated: 2017-04-14
Results Overview
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2017-04-14
Participant Flow
Participant milestones
| Measure |
Arm I (Capecitabine, Vorinostat)
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Capecitabine, Vorinostat)
n=25 Participants
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPer Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I (Capecitabine, Vorinostat)
n=25 Participants
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Response Rate According to Response Evaluation Criteria in Solid Tumors
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 16 patients of the 25 were eligible for response assessment.
Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Capecitabine, Vorinostat)
n=16 Participants
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Survival
|
10.8 months
Interval 5.0 to
Not reached
|
SECONDARY outcome
Timeframe: From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.Population: 16 of 25 patients were evaluable for response.
PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Arm I (Capecitabine, Vorinostat)
n=16 Participants
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Progression-free Survival
|
2.3 months
Interval 1.2 to 3.6
|
Adverse Events
Arm I (Capecitabine, Vorinostat)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Capecitabine, Vorinostat)
n=25 participants at risk
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Other: diverticulitis
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Ischemia cerbrovascular
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal fistula
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Arm I (Capecitabine, Vorinostat)
n=25 participants at risk
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Vorinostat: Given PO
|
|---|---|
|
General disorders
Fatigue
|
92.0%
23/25
|
|
Investigations
Lymphocyte count decreased
|
84.0%
21/25
|
|
Blood and lymphatic system disorders
Anemia
|
64.0%
16/25
|
|
Gastrointestinal disorders
Nausea
|
56.0%
14/25
|
|
Gastrointestinal disorders
Vomiting
|
56.0%
14/25
|
|
Metabolism and nutrition disorders
Anorexia
|
52.0%
13/25
|
|
Metabolism and nutrition disorders
Hyponatremia
|
48.0%
12/25
|
|
Gastrointestinal disorders
Constipation
|
44.0%
11/25
|
|
Investigations
Platelet count decreased
|
40.0%
10/25
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysethesia syndrome
|
40.0%
10/25
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
10/25
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
10/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
10/25
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
10/25
|
|
Vascular disorders
Hypertension
|
40.0%
10/25
|
|
Psychiatric disorders
Insomnia
|
36.0%
9/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
8/25
|
|
Gastrointestinal disorders
Dry mouth
|
32.0%
8/25
|
|
Gastrointestinal disorders
Diarrhea
|
32.0%
8/25
|
|
Investigations
Creatinine increased
|
28.0%
7/25
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.0%
7/25
|
|
Nervous system disorders
Dysgeusia
|
28.0%
7/25
|
|
Ear and labyrinth disorders
Hearing impaired
|
28.0%
7/25
|
|
Investigations
White blood cell decreased
|
24.0%
6/25
|
|
Nervous system disorders
Headache
|
24.0%
6/25
|
|
Ear and labyrinth disorders
Tinnitus
|
24.0%
6/25
|
|
Endocrine disorders
Hypothyroidism
|
24.0%
6/25
|
|
Psychiatric disorders
Anxiety
|
24.0%
6/25
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
24.0%
6/25
|
|
Psychiatric disorders
Depression
|
20.0%
5/25
|
|
General disorders
Edema limbs
|
20.0%
5/25
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
5/25
|
|
Investigations
Weight loss
|
20.0%
5/25
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
5/25
|
|
Gastrointestinal disorders
Abdominal pain
|
16.0%
4/25
|
|
General disorders
Facial pain
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.0%
4/25
|
|
Renal and urinary disorders
Urinary frequency
|
16.0%
4/25
|
|
General disorders
Edena face
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.0%
4/25
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25
|
|
Psychiatric disorders
Confusion
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
12.0%
3/25
|
|
Investigations
Blood bilirubin increased
|
12.0%
3/25
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.0%
3/25
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25
|
|
Investigations
Neutrophil count decreased
|
12.0%
3/25
|
|
Ear and labyrinth disorders
Ear pain
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25
|
|
General disorders
Pain
|
8.0%
2/25
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Bruising
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
2/25
|
|
Investigations
Alkaline phosphatase increased
|
8.0%
2/25
|
|
Vascular disorders
Thromboembolic event
|
8.0%
2/25
|
|
Investigations
Aspartate amino transferase increased
|
8.0%
2/25
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25
|
|
Eye disorders
Dry eye
|
8.0%
2/25
|
|
General disorders
Flu like symptoms
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Repiratory failure
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
2/25
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.0%
1/25
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.0%
1/25
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25
|
|
Investigations
INR increased
|
4.0%
1/25
|
|
Psychiatric disorders
Agitation
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.0%
1/25
|
|
Cardiac disorders
Atrial fibrilation
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.0%
1/25
|
|
Investigations
Weight gain
|
4.0%
1/25
|
|
Eye disorders
Cataract
|
4.0%
1/25
|
|
Nervous system disorders
Somnolence
|
4.0%
1/25
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
4.0%
1/25
|
|
General disorders
Fever
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.0%
1/25
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
1/25
|
|
Gastrointestinal disorders
Cheilitis
|
4.0%
1/25
|
|
Vascular disorders
Hot flashes
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
1/25
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.0%
1/25
|
|
General disorders
Chills
|
4.0%
1/25
|
|
Renal and urinary disorders
Hematuria
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Obesity
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.0%
1/25
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25
|
|
General disorders
Gait disturbance
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25
|
|
Nervous system disorders
Dysarthria
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.0%
1/25
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.0%
1/25
|
|
Nervous system disorders
Hypersomnia
|
4.0%
1/25
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.0%
1/25
|
Additional Information
Dr.Eric Chen, Principal Investigator
Princess Margaret Cancer Centre
Phone: 416-946-4501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60