Trial Outcomes & Findings for Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146) (NCT NCT00632203)
NCT ID: NCT00632203
Last Updated: 2017-06-07
Results Overview
Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Temozolomide Treatment
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
Observation
Observation
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Temozolomide Treatment
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
Observation
Observation
|
|---|---|---|
|
Overall Study
Did not start study treatment
|
1
|
0
|
Baseline Characteristics
Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146)
Baseline characteristics by cohort
| Measure |
Temozolomide Treatment
n=26 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
Observation
n=27 Participants
Observation
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)Population: Evaluable population, defined as a participant who had at least one post-randomization MRI scan
Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Observation
n=23 Participants
Observation
|
Temozolomide Treatment
n=22 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
|---|---|---|
|
Number of Participants Who Had Brain Metastases
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free dateDefined as CNS progression as measured by MRI. Time to CNS progression was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Observation
n=27 Participants
Observation
|
Temozolomide Treatment
n=26 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
|---|---|---|
|
Time to Radiological Central Nervous System (CNS) Progression
|
NA months
NA means "not applicable." The median and CI could not be calculated because they were not reached before the study termination date.
|
NA months
Interval 14.26 to
NA means "not applicable." The median and upper limit of the confidence interval (CI) could not be calculated because they were not reached before the study termination date.
|
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatmentThe time to progression (per response evaluation criteria in solid tumors \[RECIST\]) was analyzed using the Kaplan-Meier method. Definitions of response per RECIST: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): A decrease of at least 30% in the sum of the longest diameter of target lesions. Progressive Disease (PD): An increase of at least 20% in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Observation
n=27 Participants
Observation
|
Temozolomide Treatment
n=26 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
|---|---|---|
|
Time to Progression
|
10.68 months
Interval 8.54 to 12.68
|
11.70 months
Interval 9.03 to 15.8
|
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-upThe overall survival was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Observation
n=27 Participants
Observation
|
Temozolomide Treatment
n=26 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
|---|---|---|
|
Overall Survival
|
22.54 months
Interval 14.52 to
NA means "not applicable." The upper limit of the CI could not be calculated because it was not reached before the study termination date.
|
27.14 months
Interval 13.9 to
NA means "not applicable." The upper limit of the confidence interval (CI) could not be calculated because it was not reached before the study termination date.
|
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)Population: No analysis was performed due to study termination.
Brain Metastases were defined as radiological evidence of brain metastases on MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)Population: No analysis was performed due to study termination.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.
Outcome measures
| Measure |
Observation
n=27 Participants
Observation
|
Temozolomide Treatment
n=26 Participants
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
|---|---|---|
|
Tolerability of Maintenance Temozolomide
|
NA participants
|
5 participants
|
Adverse Events
Temozolomide Treatment
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Observation
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide Treatment
n=26 participants at risk
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
Observation
n=27 participants at risk
Observation
|
|---|---|---|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
CHEST PAIN
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
|
General disorders
PYREXIA
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
PNEUMONIA
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
COGNITIVE DISORDER
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
DYSARTHRIA
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
HEMIPARESIS
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
HYPOTENSION
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
Other adverse events
| Measure |
Temozolomide Treatment
n=26 participants at risk
Participants received temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
|
Observation
n=27 participants at risk
Observation
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
15.4%
4/26 • Number of events 14
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
7.7%
2/26 • Number of events 9
|
0.00%
0/27
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.4%
4/26 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
19.2%
5/26 • Number of events 5
|
14.8%
4/27 • Number of events 4
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
13/26 • Number of events 17
|
18.5%
5/27 • Number of events 5
|
|
Gastrointestinal disorders
STOMATITIS
|
11.5%
3/26 • Number of events 3
|
0.00%
0/27
|
|
Gastrointestinal disorders
VOMITING
|
23.1%
6/26 • Number of events 8
|
7.4%
2/27 • Number of events 2
|
|
General disorders
ASTHENIA
|
7.7%
2/26 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
|
General disorders
CHEST PAIN
|
7.7%
2/26 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
General disorders
CHILLS
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
General disorders
FATIGUE
|
57.7%
15/26 • Number of events 16
|
14.8%
4/27 • Number of events 5
|
|
General disorders
PAIN
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 2
|
|
General disorders
PYREXIA
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Infections and infestations
PNEUMONIA
|
11.5%
3/26 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
15.4%
4/26 • Number of events 5
|
11.1%
3/27 • Number of events 6
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
CONTUSION
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Investigations
WEIGHT DECREASED
|
15.4%
4/26 • Number of events 4
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
19.2%
5/26 • Number of events 5
|
14.8%
4/27 • Number of events 4
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
11.5%
3/26 • Number of events 3
|
3.7%
1/27 • Number of events 2
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.5%
3/26 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.5%
3/26 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
23.1%
6/26 • Number of events 7
|
14.8%
4/27 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
7.7%
2/26 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
Nervous system disorders
DIZZINESS
|
19.2%
5/26 • Number of events 5
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
7.7%
2/26 • Number of events 2
|
14.8%
4/27 • Number of events 4
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
|
Psychiatric disorders
ANXIETY
|
7.7%
2/26 • Number of events 3
|
11.1%
3/27 • Number of events 3
|
|
Psychiatric disorders
DEPRESSION
|
3.8%
1/26 • Number of events 1
|
18.5%
5/27 • Number of events 5
|
|
Psychiatric disorders
INSOMNIA
|
7.7%
2/26 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
26.9%
7/26 • Number of events 10
|
25.9%
7/27 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/26
|
11.1%
3/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.5%
3/26 • Number of events 3
|
11.1%
3/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.8%
1/26 • Number of events 1
|
11.1%
3/27 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
3.8%
1/26 • Number of events 1
|
14.8%
4/27 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.5%
3/26 • Number of events 5
|
11.1%
3/27 • Number of events 3
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish/publicly present any interim results of the study without prior written consent from the Sponsor. The PI further agrees to provide 45 days written notice to the Sponsor prior to submission, to permit the Sponsor to review copies of abstracts/manuscripts for publication, which report any results of the study. The Sponsor shall have the right to review and comment on any presentation.
- Publication restrictions are in place
Restriction type: OTHER