Trial Outcomes & Findings for Study of Temozolomide to Treat Newly Diagnosed Brain Metastases (NCT NCT00717275)

NCT ID: NCT00717275

Last Updated: 2012-10-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2012-10-01

Participant Flow

Participants were recruited from the investigator's clinical practice between September 2008 and January 2011.

Participant milestones

Measure	Temozolomide Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Temozolomide Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
Overall Study Premature study termination.	3

Baseline Characteristics

Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

Baseline characteristics by cohort

Measure	Temozolomide n=3 Participants Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Data was not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Temozolomide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Temozolomide n=3 participants at risk Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
Metabolism and nutrition disorders ALT	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Metabolism and nutrition disorders AST	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Metabolism and nutrition disorders Alkaline phosphatase	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Renal and urinary disorders Bladder infection	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Eye disorders Blurred vision	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Musculoskeletal and connective tissue disorders Fatigue	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Nervous system disorders Headache	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Blood and lymphatic system disorders Hemoglobin	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Metabolism and nutrition disorders Hypernatremia	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Metabolism and nutrition disorders Hypoglycemia	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
General disorders Insomnia	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Musculoskeletal and connective tissue disorders Muscloskeletal pain	66.7% 2/3 • Number of events 2 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Nervous system disorders Neuropathy	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Blood and lymphatic system disorders Platelets	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Skin and subcutaneous tissue disorders Pruritis	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Respiratory, thoracic and mediastinal disorders Respiratory infection	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.
Blood and lymphatic system disorders Swollen lymph node	33.3% 1/3 • Number of events 1 • Adverse event monitoring began after the first dose of temozolomide and continued until study termination.

Additional Information

Dr. Erin M. Dunbar

University of Florida

Phone: 352-273-9000

Email: edunbar@neurosurgery.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place