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Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
This study has been completed.
Study NCT00684567   Information provided by Schering-Plough
First Received: May 22, 2008   Last Updated: September 25, 2009   History of Changes
Study Type: Interventional
Study Design: Open Label, Uncontrolled, Single Group Assignment
Condition: Glioblastoma
Interventions: Radiation: Radiotherapy
Drug: Temozolomide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Radiotherapy/Temozolomide It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Participant Flow for 2 periods
Period:   Concomitant Radiotherapy Period
  Radiotherapy/Temozolomide
STARTED   30  
COMPLETED   28  
NOT COMPLETED   2  
      Adverse Event               2  

Period:   Monotherapy Period
  Radiotherapy/Temozolomide
STARTED   23[1]
COMPLETED   9  
NOT COMPLETED   14  
      Adverse Event               2  
      Death               1  
      Progression of primary disease               11  
[1] 5 subjects completed radiotherapy combined therapy phase but did not proceed to monotherapy phase.



  Baseline Characteristics
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Reporting Groups
  Description
Radiotherapy/Temozolomide It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Baseline Measures
  Radiotherapy/Temozolomide
Number of Participants  
[units: participants]
 		30
Age  
[units: years]
Mean ± Standard Deviation 		54.2 ± 9.4
Gender  
[units: Participants]
 		 
Female 16
Male 14
Centralized Pathologic Diagnosis  
[units: Participants]
 		 
High Grade Astrocytoma 1
Glioblastoma Multiforme 27
Anaplastic Astrocytoma 1
Gliosarcoma 1
Eastern Cooperative Oncology Group (ECOG) Performance Status[1]
[units: Participants]
 		 
0 14
1 11
2 5
3 0
4 0
5 0
Type of Surgery  
[units: Participants]
 		 
Radical Extraction 7
Partial Extraction 21
Biopsy 2
[1] 6-point, ordinal scale specifying patient's ability to perform activities from 0 (fully active) to 5 (dead).



  Outcome Measures
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1.  Primary:   Adverse Events With an Incidence of Greater Than or Equal to 20%   [ until 30 days after the completion of administration of monotherapy ]
  Show Outcome Measure 1

2.  Primary:   Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%   [ until 30 days after the completion of administration of monotherapy ]
  Show Outcome Measure 2

3.  Primary:   Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%   [ until 30 days after the completion of administration of monotherapy ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Progression Free Survival (PFS) for 1 Year   [ 1 year after the start of admininstration in the concomitant radiotherapy phase ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response   [ 1 year after the start of administration in the concomitant radiotherapy phase ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Radiotherapy/Temozolomide No text entered.

Other Adverse Events
  Radiotherapy/Temozolomide
Total, other (not including serious) adverse events  
# participants affected / at risk 30  
Ear and labyrinth disorders  
EAR DISCOMFORT   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
Eye disorders  
EYE PAIN   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
VISUAL DISTURBANCE   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
Gastrointestinal disorders  
ABDOMINAL DISTENSION   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
ABDOMINAL PAIN   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
CONSTIPATION   † A
      # participants affected / at risk
      # events
15/30 (50.00%)
19  
DIARRHOEA   † A
      # participants affected / at risk
      # events
7/30 (23.33%)
12  
GASTRITIS   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
HAEMORRHOIDS   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
NAUSEA   † A
      # participants affected / at risk
      # events
17/30 (56.67%)
21  
STOMACH DISCOMFORT   † A
      # participants affected / at risk
      # events
5/30 (16.67%)
7  
STOMATITIS   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
3  
VOMITING   † A
      # participants affected / at risk
      # events
9/30 (30.00%)
17  
General disorders  
FATIGUE   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
3  
INFLAMMATION OF WOUND   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
MALAISE   † A
      # participants affected / at risk
      # events
14/30 (46.67%)
23  
PYREXIA   † A
      # participants affected / at risk
      # events
5/30 (16.67%)
7  
Infections and infestations  
NASOPHARYNGITIS   † A
      # participants affected / at risk
      # events
8/30 (26.67%)
9  
OTITIS EXTERNA   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
Injury, poisoning and procedural complications  
RADIATION SKIN INJURY   † A
      # participants affected / at risk
      # events
5/30 (16.67%)
5  
SUTURE RELATED COMPLICATION   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
WOUND COMPLICATION   † A
      # participants affected / at risk
      # events
6/30 (20.00%)
7  
Investigations  
ALANINE AMINOTRANSFERASE INCREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
6  
ASPARTATE AMINOTRANSFERASE INCREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
3  
BASOPHIL PERCENTAGE INCREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
BLOOD ALBUMIN DECREASED   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
BLOOD ALKALINE PHOSPHATASE INCREASED   † A
      # participants affected / at risk
      # events
5/30 (16.67%)
7  
BLOOD CHLORIDE DECREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
BLOOD LACTATE DEHYDROGENASE INCREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
BLOOD PRESSURE SYSTOLIC INCREASED   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
4  
BLOOD UREA INCREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
5  
C-REACTIVE PROTEIN INCREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
EOSINOPHIL PERCENTAGE INCREASED   † A
      # participants affected / at risk
      # events
10/30 (33.33%)
16  
GAMMA-GLUTAMYLTRANSFERASE INCREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
HAEMOGLOBIN DECREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
LYMPHOCYTE COUNT DECREASED   † A
      # participants affected / at risk
      # events
25/30 (83.33%)
43  
MONOCYTE PERCENTAGE INCREASED   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
7  
NEUTROPHIL COUNT DECREASED   † A
      # participants affected / at risk
      # events
7/30 (23.33%)
12  
PLATELET COUNT DECREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
PROTEIN TOTAL DECREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
WEIGHT DECREASED   † A
      # participants affected / at risk
      # events
11/30 (36.67%)
15  
WEIGHT INCREASED   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
WHITE BLOOD CELL COUNT DECREASED   † A
      # participants affected / at risk
      # events
14/30 (46.67%)
28  
Metabolism and nutrition disorders  
ANOREXIA   † A
      # participants affected / at risk
      # events
17/30 (56.67%)
28  
Musculoskeletal and connective tissue disorders  
BACK PAIN   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
MUSCULOSKELETAL STIFFNESS   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
NECK PAIN   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
PAIN IN EXTREMITY   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
Nervous system disorders  
CONVULSION   † A
      # participants affected / at risk
      # events
6/30 (20.00%)
11  
DIZZINESS   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
DYSKINESIA   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
HEADACHE   † A
      # participants affected / at risk
      # events
10/30 (33.33%)
18  
HEMIPLEGIA   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
HYPOAESTHESIA   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
4  
MEMORY IMPAIRMENT   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
SENSORY DISTURBANCE   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
SOMNOLENCE   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
TREMOR   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
Psychiatric disorders  
INSOMNIA   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
6  
Reproductive system and breast disorders  
MENSTRUAL DISORDER   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
Respiratory, thoracic and mediastinal disorders  
COUGH   † A
      # participants affected / at risk
      # events
3/30 (10.00%)
3  
DYSPNOEA   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
PHARYNGOLARYNGEAL PAIN   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
UPPER RESPIRATORY TRACT INFLAMMATION   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
Skin and subcutaneous tissue disorders  
ALOPECIA   † A
      # participants affected / at risk
      # events
25/30 (83.33%)
25  
DRUG ERUPTION   † A
      # participants affected / at risk
      # events
4/30 (13.33%)
4  
DRY SKIN   † A
      # participants affected / at risk
      # events
8/30 (26.67%)
10  
ERYTHEMA   † A
      # participants affected / at risk
      # events
5/30 (16.67%)
7  
PIGMENTATION DISORDER   † A
      # participants affected / at risk
      # events
2/30 (6.67%)
2  
PRURITUS   † A
      # participants affected / at risk
      # events
6/30 (20.00%)
7  
RASH   † A
      # participants affected / at risk
      # events
11/30 (36.67%)
18  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 11.0


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04661, JPC-05-351-22
Study First Received: May 22, 2008
Results First Received: October 31, 2008
Last Updated: September 25, 2009
ClinicalTrials.gov Identifier: NCT00684567     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency





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