Trial Outcomes & Findings for Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients (NCT NCT00350792)
NCT ID: NCT00350792
Last Updated: 2010-10-13
Results Overview
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
COMPLETED
PHASE2
62 participants
baseline to measured objective tumor response (up to six 21-day cycles)
2010-10-13
Participant Flow
Participant milestones
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Pemetrexed + Carboplatin
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death from Study Disease
|
1
|
|
Overall Study
Death from Study Drug Toxicity
|
1
|
|
Overall Study
Death Not Study Drug Related
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lack of Efficacy
|
11
|
Baseline Characteristics
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Baseline characteristics by cohort
| Measure |
Pemetrexed + Carboplatin
n=62 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Age Continuous
|
76.5 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
62 participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
13 participants
n=5 Participants
|
|
Disease Stage
Stage IV
|
49 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
10 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
52 participants
n=5 Participants
|
|
Pathological Diagnosis
Large Cell Lung Cancer
|
5 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of Lung
|
32 participants
n=5 Participants
|
|
Pathological Diagnosis
Squamous Cell Carcinoma of Lung
|
21 participants
n=5 Participants
|
|
Pathological Diagnosis
Other: Carcinoma-Infiltrant Indifferencie
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Other: Carcinoma
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Other: Indifferencied Non-Small Cell Lung Cancer
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Other: Undifferentiated
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured objective tumor response (up to six 21-day cycles)Population: Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=49 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
|
28.6 percentage of participants
Interval 16.58 to 43.26
|
SECONDARY outcome
Timeframe: baseline to stopping treatment (up to six 21-day cycles)Population: All treated patients. 29 patients were censored.
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=62 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Time to Treatment Failure
|
16.0 weeks
Interval 10.1 to
Confidence interval is not calculable for the upper limit due to the immaturity of the data.
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (up to 14.5 months)Population: Twenty patients were censored as they were still alive at the time of the data cut-off.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=62 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Overall Survival
|
10.4 months
Interval 9.1 to 12.9
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death, 1 yearPopulation: Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.
Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=62 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Estimated Probability of One Year Progression-free Survival
|
13.1 percentage of patients
Interval 4.6 to 21.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to stopping treatment (up to six 21-day cycles)Population: All treated patients. 29 patients were censored.
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=62 Participants
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Time to Treatment Failure
|
12.95 weeks
Standard Error 0.74
|
Adverse Events
Pemetrexed + Carboplatin
Serious adverse events
| Measure |
Pemetrexed + Carboplatin
n=62 participants at risk
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
4/62 • Number of events 5
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.6%
1/62 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.6%
1/62 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/62 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/62 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
3/62 • Number of events 4
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.6%
1/62 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
4/62 • Number of events 6
|
|
Cardiac disorders
Arrhythmia
|
1.6%
1/62 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.6%
1/62 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/62 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/62 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Sigmoiditis
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Number of events 1
|
|
General disorders
Fatigue
|
1.6%
1/62 • Number of events 1
|
|
General disorders
General physical health deterioration
|
6.5%
4/62 • Number of events 4
|
|
General disorders
Mucosal inflammation
|
1.6%
1/62 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.2%
2/62 • Number of events 2
|
|
Infections and infestations
Septic shock
|
1.6%
1/62 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.6%
1/62 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.6%
1/62 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/62 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/62 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.6%
1/62 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
6/62 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/62 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.6%
1/62 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Carboplatin
n=62 participants at risk
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
56.5%
35/62 • Number of events 43
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.4%
12/62 • Number of events 23
|
|
Blood and lymphatic system disorders
Neutropenia
|
71.0%
44/62 • Number of events 115
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.8%
29/62 • Number of events 68
|
|
Gastrointestinal disorders
Constipation
|
33.9%
21/62 • Number of events 26
|
|
Gastrointestinal disorders
Diarrhoea
|
19.4%
12/62 • Number of events 14
|
|
Gastrointestinal disorders
Nausea
|
33.9%
21/62 • Number of events 32
|
|
Gastrointestinal disorders
Stomatitis
|
6.5%
4/62 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
14/62 • Number of events 17
|
|
General disorders
Asthenia
|
67.7%
42/62 • Number of events 63
|
|
General disorders
Chest pain
|
11.3%
7/62 • Number of events 7
|
|
General disorders
Oedema peripheral
|
8.1%
5/62 • Number of events 5
|
|
General disorders
Pyrexia
|
9.7%
6/62 • Number of events 12
|
|
Investigations
Weight decreased
|
37.1%
23/62 • Number of events 24
|
|
Investigations
Weight increased
|
6.5%
4/62 • Number of events 4
|
|
Investigations
White blood cell count decreased
|
6.5%
4/62 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
40.3%
25/62 • Number of events 30
|
|
Psychiatric disorders
Insomnia
|
11.3%
7/62 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
10/62 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.7%
11/62 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.7%
6/62 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.5%
4/62 • Number of events 5
|
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