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Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00423150
Recruitment Status : Terminated
First Posted : January 18, 2007
Results First Posted : July 5, 2010
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Neoplasm
Head and Neck Neoplasm
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasm
Intervention Drug: Temozolomide
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide
Hide Arm/Group Description Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
Period Title: Overall Study
Started 86
Completed 0
Not Completed 86
Reason Not Completed
Adverse Event             11
Progression of disease being studied             69
Withdrawal by Subject             1
Non-compliance with protocol             1
Administrative             4
Arm/Group Title Temozolomide
Hide Arm/Group Description Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
Overall Number of Baseline Participants 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants
62.9  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Female
29
  33.7%
Male
57
  66.3%
1.Primary Outcome
Title Tumor Responses (Complete and Partial Response)
Hide Description

Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).

Complete Response (CR): Disappearance of all target lesions.

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Time Frame From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Hide Outcome Measure Data
Hide Analysis Population Description

Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).

Complete response is defined as disappearance of all target lesions.

Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Arm/Group Title Temozolomide
Hide Arm/Group Description:
Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: Participants
Number of participants with Complete Response 0
Number of participants with Partial Response 5
Time Frame [Not Specified]
Adverse Event Reporting Description Other adverse events: these non-serious events are treatment-emergent.
 
Arm/Group Title Temozolomide
Hide Arm/Group Description Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
All-Cause Mortality
Temozolomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Temozolomide
Affected / at Risk (%) # Events
Total   37/86 (43.02%)    
Blood and lymphatic system disorders   
ANAEMIA  1  4/86 (4.65%)  4
FEBRILE NEUTROPENIA  1  1/86 (1.16%)  1
LEUKOPENIA  1  1/86 (1.16%)  1
NEUTROPENIA  1  2/86 (2.33%)  5
THROMBOCYTOPENIA  1  4/86 (4.65%)  7
Cardiac disorders   
ACUTE MYOCARDIAL INFARCTION  1  2/86 (2.33%)  2
ATRIAL FIBRILLATION  1  3/86 (3.49%)  3
CARDIO-RESPIRATORY ARREST  1  1/86 (1.16%)  1
Ear and labyrinth disorders   
VERTIGO  1  2/86 (2.33%)  2
Gastrointestinal disorders   
DYSPHAGIA  1  1/86 (1.16%)  1
GASTROINTESTINAL HAEMORRHAGE  1  1/86 (1.16%)  1
MELAENA  1  1/86 (1.16%)  1
NAUSEA  1  1/86 (1.16%)  1
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/86 (1.16%)  1
VOMITING  1  3/86 (3.49%)  4
General disorders   
FATIGUE  1  2/86 (2.33%)  2
MULTI-ORGAN FAILURE  1  1/86 (1.16%)  1
PYREXIA  1  3/86 (3.49%)  3
Hepatobiliary disorders   
BILE DUCT OBSTRUCTION  1  1/86 (1.16%)  1
HYPERBILIRUBINAEMIA  1  1/86 (1.16%)  1
Infections and infestations   
BACTERAEMIA  1  1/86 (1.16%)  1
PNEUMONIA  1  1/86 (1.16%)  2
Injury, poisoning and procedural complications   
ACCIDENTAL OVERDOSE  1  1/86 (1.16%)  1
ACETABULUM FRACTURE  1  1/86 (1.16%)  1
Investigations   
BLOOD CREATININE INCREASED  1  1/86 (1.16%)  1
BLOOD UREA INCREASED  1  1/86 (1.16%)  2
OXYGEN CONSUMPTION INCREASED  1  1/86 (1.16%)  1
Metabolism and nutrition disorders   
ANOREXIA  1  1/86 (1.16%)  1
DEHYDRATION  1  3/86 (3.49%)  3
HYPERCALCAEMIA  1  1/86 (1.16%)  1
HYPERGLYCAEMIA  1  1/86 (1.16%)  1
HYPOKALAEMIA  1  1/86 (1.16%)  1
HYPONATRAEMIA  1  1/86 (1.16%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/86 (1.16%)  1
PATHOLOGICAL FRACTURE  1  1/86 (1.16%)  1
Nervous system disorders   
CEREBRAL ARTERY THROMBOSIS  1  1/86 (1.16%)  1
CONVULSION  1  1/86 (1.16%)  1
DIZZINESS  1  1/86 (1.16%)  1
HEPATIC ENCEPHALOPATHY  1  1/86 (1.16%)  1
HYPOAESTHESIA  1  1/86 (1.16%)  1
SPINAL CORD COMPRESSION  1  1/86 (1.16%)  1
Psychiatric disorders   
CONFUSIONAL STATE  1  1/86 (1.16%)  1
Renal and urinary disorders   
HAEMATURIA  1  1/86 (1.16%)  1
RENAL FAILURE  1  1/86 (1.16%)  1
RENAL FAILURE ACUTE  1  1/86 (1.16%)  1
Respiratory, thoracic and mediastinal disorders   
ACUTE PULMONARY OEDEMA  1  1/86 (1.16%)  1
DYSPNOEA  1  5/86 (5.81%)  6
DYSPNOEA EXERTIONAL  1  1/86 (1.16%)  1
HAEMOPTYSIS  1  1/86 (1.16%)  1
HYPOXIA  1  2/86 (2.33%)  2
INCREASED UPPER AIRWAY SECRETION  1  1/86 (1.16%)  1
PLEURAL EFFUSION  1  1/86 (1.16%)  1
PULMONARY OEDEMA  1  1/86 (1.16%)  1
RESPIRATORY ACIDOSIS  1  1/86 (1.16%)  1
RESPIRATORY FAILURE  1  1/86 (1.16%)  1
Surgical and medical procedures   
NEPHROSTOMY TUBE REMOVAL  1  1/86 (1.16%)  1
Vascular disorders   
HYPERTENSION  1  1/86 (1.16%)  1
HYPOTENSION  1  1/86 (1.16%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide
Affected / at Risk (%) # Events
Total   83/86 (96.51%)    
Blood and lymphatic system disorders   
ANAEMIA  1  17/86 (19.77%)  30
LYMPHOPENIA  1  9/86 (10.47%)  18
THROMBOCYTOPENIA  1  19/86 (22.09%)  55
Gastrointestinal disorders   
ABDOMINAL PAIN  1  9/86 (10.47%)  13
CONSTIPATION  1  22/86 (25.58%)  25
DIARRHOEA  1  21/86 (24.42%)  37
GASTROOESOPHAGEAL REFLUX DISEASE  1  5/86 (5.81%)  8
NAUSEA  1  45/86 (52.33%)  84
VOMITING  1  35/86 (40.70%)  53
General disorders   
ASTHENIA  1  10/86 (11.63%)  13
FATIGUE  1  36/86 (41.86%)  75
OEDEMA PERIPHERAL  1  7/86 (8.14%)  10
PYREXIA  1  7/86 (8.14%)  13
Infections and infestations   
LOWER RESPIRATORY TRACT INFECTION  1  6/86 (6.98%)  6
Investigations   
PLATELET COUNT DECREASED  1  5/86 (5.81%)  9
WEIGHT DECREASED  1  13/86 (15.12%)  13
Metabolism and nutrition disorders   
ANOREXIA  1  31/86 (36.05%)  33
HYPERGLYCAEMIA  1  7/86 (8.14%)  11
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  6/86 (6.98%)  6
MUSCULOSKELETAL CHEST PAIN  1  5/86 (5.81%)  9
MUSCULOSKELETAL PAIN  1  5/86 (5.81%)  6
Nervous system disorders   
DIZZINESS  1  11/86 (12.79%)  16
HEADACHE  1  13/86 (15.12%)  27
NEUROPATHY PERIPHERAL  1  6/86 (6.98%)  6
Psychiatric disorders   
ANXIETY  1  5/86 (5.81%)  5
INSOMNIA  1  7/86 (8.14%)  8
Respiratory, thoracic and mediastinal disorders   
COUGH  1  11/86 (12.79%)  12
DYSPNOEA  1  9/86 (10.47%)  9
Skin and subcutaneous tissue disorders   
PRURITUS  1  7/86 (8.14%)  8
RASH  1  12/86 (13.95%)  17
Vascular disorders   
HYPOTENSION  1  6/86 (6.98%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Due to low response rate for colorectal cancer in interim analyses, low enrollment in head & neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

The investigator agrees not to publish or publicly present any interim results

of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor, 45 days prior to submission, review copies of abstracts or manuscripts for publication that report any results of the study. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission, for the purpose of making good faith efforts to discuss/resolve any such issues.

Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00423150     History of Changes
Other Study ID Numbers: P04273
First Submitted: November 30, 2006
First Posted: January 18, 2007
Results First Submitted: May 27, 2010
Results First Posted: July 5, 2010
Last Update Posted: June 8, 2017