Trial Outcomes & Findings for Study of Capecitabine to Treat Recurrent High Grade Gliomas (NCT NCT00717197)
NCT ID: NCT00717197
Last Updated: 2013-07-02
Results Overview
Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (\~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From date of first dose of study drug until month 6.
Results posted on
2013-07-02
Participant Flow
Participants were recruited from the investigator's clinical practice from October 2008 thru June 2011.
30 participants were enrolled in the study. 7 were excluded from participation prior to group assignment \[5 were unable to purchase study drug; 1 had rapid tumor growth; and, 1 was withdrawn by the investigator for mental health reasons\].
Participant milestones
| Measure |
Capecitabine
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Capecitabine
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Unable to purchase study drug
|
5
|
|
Overall Study
Tumor Progression
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study of Capecitabine to Treat Recurrent High Grade Gliomas
Baseline characteristics by cohort
| Measure |
Capecitabine
n=30 Participants
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
51.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of first dose of study drug until month 6.Population: Per protocol
Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (\~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.
Outcome measures
| Measure |
Capecitabine
n=23 Participants
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Progression-free Survival.
|
21.7 percentage of participants with PFS6
Interval 7.46 to 43.7
|
Adverse Events
Capecitabine
Serious events: 21 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine
n=23 participants at risk
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Mental Status
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Death
|
91.3%
21/23 • Number of events 21 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Fever
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gait
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dairrhea
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Ataxia
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Levetiracetam, Low Level
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Phenytoin, High Level
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
Other adverse events
| Measure |
Capecitabine
n=23 participants at risk
Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
ALT
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Mood Alteration
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Speech Impairement
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
AST
|
13.0%
3/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Ataxia
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Bilirubin
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Eye disorders
Blindness
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Eye disorders
Blurred Vision
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Cholesterol
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Cognitive Disturbance
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Confusion
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
26.1%
6/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
6/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
13.0%
3/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Edema
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
43.5%
10/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.7%
5/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hand-foot Skin Reaction
|
21.7%
5/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Heartburn
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Infections and infestations
Infection
|
13.0%
3/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Insomnia
|
13.0%
3/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
3/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Neuropathy
|
34.8%
8/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
General disorders
Pain
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Platelets
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Seizure
|
17.4%
4/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytes
|
8.7%
2/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23 • Adverse events were collected beginning with the first dose of study drug and continuing until 14 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place