Trial Outcomes & Findings for Chemotherapy for Patients With Non-Small Cell Lung Cancer (NCT NCT00380718)
NCT ID: NCT00380718
Last Updated: 2010-11-16
Results Overview
The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
COMPLETED
PHASE4
33 participants
baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
2010-11-16
Participant Flow
Thirty-seven participants were screened; 3 did not meet inclusion/exclusion criteria and one withdrew.
Participant milestones
| Measure |
Pemetrexed
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Received at Least One Dose of Study Drug
|
33
|
|
Overall Study
Received Escalated Dose in Cycle 2
|
25
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Pemetrexed
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death after 30-day post-therapy followup
|
17
|
Baseline Characteristics
Chemotherapy for Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Age Continuous
|
58.0 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
33 participants
n=5 Participants
|
|
Disease Characteristic: Basis for Diagnosis
Histopathological
|
17 participants
n=5 Participants
|
|
Disease Characteristic: Basis for Diagnosis
Cytological
|
16 participants
n=5 Participants
|
|
Disease Characteristic: Disease Stage at Study Entry
Stage IIIB
|
3 participants
n=5 Participants
|
|
Disease Characteristic: Disease Stage at Study Entry
Stage IV
|
30 participants
n=5 Participants
|
|
Disease Characteristic: Eastern Cooperative Oncology Group Performance Status
0 - Fully Active
|
9 participants
n=5 Participants
|
|
Disease Characteristic: Eastern Cooperative Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
24 participants
n=5 Participants
|
|
Disease Characterstic: Pathological Diagnosis Code
Adenocarcinoma of Lung
|
23 participants
n=5 Participants
|
|
Disease Characterstic: Pathological Diagnosis Code
Large Cell Carcinoma of Lung
|
1 participants
n=5 Participants
|
|
Disease Characterstic: Pathological Diagnosis Code
Mixed Cell
|
0 participants
n=5 Participants
|
|
Disease Characterstic: Pathological Diagnosis Code
Squamous Cell Carcinoma of Lung
|
8 participants
n=5 Participants
|
|
Disease Characterstic: Pathological Diagnosis Code
Non-Small Cell Lung Carcinoma
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
East/Southeast Asian
|
33 participants
n=5 Participants
|
|
Smoking Status
Ever Smoking
|
20 participants
n=5 Participants
|
|
Smoking Status
Never Smoking
|
13 participants
n=5 Participants
|
|
24 Hour Creatinine Clearance
|
81.142 milliliters per minute (ml/min)
STANDARD_DEVIATION 24.9265 • n=5 Participants
|
|
Body Temperature
|
36.25 degrees Celcius (°C)
STANDARD_DEVIATION 0.336 • n=5 Participants
|
|
Disease Characteristic: Time from Initial Diagnosis to Prior Chemotherapy Failure
|
12.04 months
STANDARD_DEVIATION 23.764 • n=5 Participants
|
|
Disease Characteristic: Time from Initial Diagnosis to Study Entry
|
11.54 months
STANDARD_DEVIATION 20.829 • n=5 Participants
|
|
Disease Characteristic: Time from Prior Chemotherapy Failure to Study Entry
|
1.00 months
STANDARD_DEVIATION 0.486 • n=5 Participants
|
|
Heart Rate
|
87.5 beats per minute (bpm)
STANDARD_DEVIATION 15.00 • n=5 Participants
|
|
Height
|
162.0 centimeters
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Homocysteine
|
7.521 micromoles per Liter (μmol/L)
STANDARD_DEVIATION 2.6229 • n=5 Participants
|
|
Weight
|
63.08 kilograms
STANDARD_DEVIATION 9.912 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Number of participants who received at least one dose of study drug. Participants who were classified as "Unknown" were considered nonresponders rather than missing.
The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
|
0.182 proportion of responders
Interval 0.07 to 0.355
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Number of participants who received at least one dose of study drug. Participants who were classified as "Unknown" were considered nonresponders rather than missing.
DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])
|
0.545 proportion of participants
Interval 0.364 to 0.719
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)Population: Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Overall Survival
|
20.2 months
Interval 0.7 to 32.0
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Progression-Free Survival (PFS)
|
6.9 months
Interval 3.0 to 9.5
|
SECONDARY outcome
Timeframe: time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.
Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
Outcome measures
| Measure |
Pemetrexed
n=6 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Duration of Response
|
6.6 months
Interval 1.6 to 9.7
|
SECONDARY outcome
Timeframe: baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.
Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Time to Treatment Failure
|
2.9 months
Interval 1.7 to 4.9
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)Population: Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.
Outcome measures
| Measure |
Pemetrexed
n=33 Participants
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Time to Tumor Progression
|
6.9 months
Interval 3.0 to 9.5
|
Adverse Events
Pemetrexed
Serious adverse events
| Measure |
Pemetrexed
n=33 participants at risk
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Pyrexia
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Infection
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
3.0%
1/33 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=33 participants at risk
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.2%
7/33 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.2%
7/33 • Number of events 25
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.2%
5/33 • Number of events 10
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.1%
4/33 • Number of events 5
|
|
Ear and labyrinth disorders
Vertigo
|
6.1%
2/33 • Number of events 2
|
|
Eye disorders
Cataract
|
6.1%
2/33 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
15.2%
5/33 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.2%
7/33 • Number of events 10
|
|
Gastrointestinal disorders
Constipation
|
15.2%
5/33 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
3/33 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.1%
2/33 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
24.2%
8/33 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
9/33 • Number of events 12
|
|
General disorders
Asthenia
|
9.1%
3/33 • Number of events 3
|
|
General disorders
Chest pain
|
27.3%
9/33 • Number of events 10
|
|
General disorders
Fatigue
|
33.3%
11/33 • Number of events 28
|
|
General disorders
Malaise
|
18.2%
6/33 • Number of events 10
|
|
General disorders
Pyrexia
|
24.2%
8/33 • Number of events 9
|
|
Infections and infestations
Herpes virus infection
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
30.3%
10/33 • Number of events 10
|
|
Investigations
Aspartate aminotransferase increased
|
24.2%
8/33 • Number of events 8
|
|
Investigations
Blood alkaline phosphatase increased
|
12.1%
4/33 • Number of events 4
|
|
Investigations
Creatinine renal clearance decreased
|
6.1%
2/33 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
18.2%
6/33 • Number of events 8
|
|
Investigations
Lymphocyte count decreased
|
15.2%
5/33 • Number of events 17
|
|
Investigations
Lymphocyte percentage decreased
|
6.1%
2/33 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
24.2%
8/33 • Number of events 22
|
|
Investigations
White blood cell count decreased
|
21.2%
7/33 • Number of events 20
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
9/33 • Number of events 11
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.2%
7/33 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
4/33 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Number of events 3
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
12.1%
4/33 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.3%
10/33 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.2%
7/33 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.1%
3/33 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
6/33 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
27.3%
9/33 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
11/33 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.2%
7/33 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
18.2%
6/33 • Number of events 6
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60