Trial Outcomes & Findings for Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer (NCT NCT00269152)
NCT ID: NCT00269152
Last Updated: 2015-08-18
Results Overview
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities \>=Grade 3 at 30 days after last infusion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
every 21-day cycle for 4 cycles up to 30 days after last infusion
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
59
|
|
Overall Study
COMPLETED
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin
n=63 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=59 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
62 participants
n=5 Participants
|
58 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=5 Participants
|
43 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Curative Surgery Used
Pneumonectomy
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Curative Surgery Used
Lobectomy
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Curative Surgery Used
Bi-lobectomy
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Smoking History
Yes
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Smoking History
No
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Stage Ia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Stage Ib
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Stage IIa
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Stage IIb
|
30 participants
n=5 Participants
|
25 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Stage IIIa
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Stage of Disease Prior to Tumor Resection
Unknown: could have been either Stage IIIb or IV
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Adenocarcinoma of the Lung
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Squamous Carcinoma of the Lung
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Non-Small Cell Lung Cancer
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Mixed Cell (Squamous/Adeno) Carcinoma of Lung
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Large Cell Carcinoma of Lung
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Tumor Type at Initial Pathological Diagnosis
Bronchoalveolar Carcinoma
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 21-day cycle for 4 cycles up to 30 days after last infusionPopulation: Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities \>=Grade 3 at 30 days after last infusion.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=64 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=54 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
The Feasibility of Post-Surgery Chemotherapy
Participants "feasible"
|
38 participants
|
27 participants
|
|
The Feasibility of Post-Surgery Chemotherapy
Non-feasible = Early Discontinuation
|
18 participants
|
6 participants
|
|
The Feasibility of Post-Surgery Chemotherapy
Non-feasible = Lost to Follow-up
|
1 participants
|
2 participants
|
|
The Feasibility of Post-Surgery Chemotherapy
Non-feasible = Remaining Grade 3/4 Toxicity
|
4 participants
|
3 participants
|
|
The Feasibility of Post-Surgery Chemotherapy
Non-feasible = Underdosage (<95% intended dose)
|
5 participants
|
19 participants
|
SECONDARY outcome
Timeframe: every 21-day cycle for 4 cyclesPopulation: Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).
Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=64 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=54 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Grade III/IV Adverse Events
Neutropenia
|
9 participants
|
6 participants
|
|
Grade III/IV Adverse Events
Anaemia
|
0 participants
|
3 participants
|
|
Grade III/IV Adverse Events
Thrombocytopenia
|
0 participants
|
3 participants
|
|
Grade III/IV Adverse Events
Febrile neutropenia
|
0 participants
|
2 participants
|
|
Grade III/IV Adverse Events
Leukopenia
|
0 participants
|
1 participants
|
|
Grade III/IV Adverse Events
Lymphopenia
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Neutrophil count decreased
|
1 participants
|
6 participants
|
|
Grade III/IV Adverse Events
Haemoglobin count decreased
|
0 participants
|
2 participants
|
|
Grade III/IV Adverse Events
Platelet count decreased
|
1 participants
|
1 participants
|
|
Grade III/IV Adverse Events
White blood cell count decreased
|
0 participants
|
2 participants
|
|
Grade III/IV Adverse Events
Asthenia
|
4 participants
|
2 participants
|
|
Grade III/IV Adverse Events
Nausea
|
3 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Vomiting
|
3 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Fatigue
|
0 participants
|
2 participants
|
|
Grade III/IV Adverse Events
Catheter related infection
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Gamma-glutamyltransferase increased
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Anorexia
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Hyperglycaemia
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Hyperkalaemia
|
1 participants
|
0 participants
|
|
Grade III/IV Adverse Events
Psychotic disorder
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause, assessed at 3 yearsPopulation: All randomized participants. Intent to treat population.
For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=63 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=59 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Overall Survival at 3 Years
|
82.0 percent probability of survival (%)
Interval 72.4 to 91.6
|
83.2 percent probability of survival (%)
Interval 73.2 to 93.2
|
SECONDARY outcome
Timeframe: length of time disease free, assessed at 3 yearsPopulation: All randomized participants. Intent to Treat population.
For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=63 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=59 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years
|
61.2 probability of disease-free survival (%)
Interval 48.3 to 74.0
|
67.3 probability of disease-free survival (%)
Interval 54.5 to 80.1
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause assessed at 6 yearsPopulation: All randomized participants. Intent to treat population.
For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=63 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=59 Participants
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Overall Survival at 6 Years
|
72.6 percent probability of survival (%)
Interval 59.3 to 85.9
|
83.2 percent probability of survival (%)
Interval 73.2 to 93.2
|
Adverse Events
Pemetrexed + Cisplatin
Serious events: 18 serious events
Other events: 61 other events
Deaths: 0 deaths
Pemetrexed + Carboplatin
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Cisplatin
n=64 participants at risk
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=54 participants at risk
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/64 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
3.7%
2/54 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Cardiac disorders
Tachyarrhythmia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Eye disorders
Visual disturbance
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/64 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.00%
0/64 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
1.9%
1/54 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Chest pain
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
1.9%
1/54 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Erysipelas
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Psychiatric disorders
Confusional state
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Psychiatric disorders
Restlessness
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
5/64 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/64 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
1.9%
1/54 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Vascular disorders
Peripheral ischaemia
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
0.00%
0/54 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin
n=64 participants at risk
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
|
Pemetrexed + Carboplatin
n=54 participants at risk
Pemetrexed: 500 mg/m\^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml\*min, intravenous (IV), every 21 days x 4 cycles
|
|---|---|---|
|
Investigations
Weight decreased
|
4.7%
3/64 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Investigations
White blood cell count decreased
|
3.1%
2/64 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
16.7%
9/54 • Number of events 17 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Metabolism and nutrition disorders
Anorexia
|
15.6%
10/64 • Number of events 17 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
25.9%
14/54 • Number of events 19 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
4/64 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
1.9%
1/54 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Nervous system disorders
Dizziness
|
6.2%
4/64 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
12/64 • Number of events 14 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
14.8%
8/54 • Number of events 9 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.8%
5/64 • Number of events 8 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.8%
21/64 • Number of events 34 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
27.8%
15/54 • Number of events 36 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
13.0%
7/54 • Number of events 12 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Eye disorders
Conjunctivitis
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
11.1%
6/54 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Eye disorders
Keratoconjunctivitis sicca
|
1.6%
1/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Eye disorders
Lacrimation increased
|
3.1%
2/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
6/64 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
9.3%
5/54 • Number of events 6 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Constipation
|
26.6%
17/64 • Number of events 30 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
14.8%
8/54 • Number of events 10 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
5/64 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
13.0%
7/54 • Number of events 11 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
4/64 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
3.7%
2/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Nausea
|
62.5%
40/64 • Number of events 82 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
55.6%
30/54 • Number of events 60 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
3/64 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
9.3%
5/54 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Gastrointestinal disorders
Vomiting
|
32.8%
21/64 • Number of events 31 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
31.5%
17/54 • Number of events 24 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Asthenia
|
15.6%
10/64 • Number of events 22 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
24.1%
13/54 • Number of events 15 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Chest pain
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 6 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Fatigue
|
35.9%
23/64 • Number of events 40 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
38.9%
21/54 • Number of events 25 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Mucosal inflammation
|
9.4%
6/64 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
3.7%
2/54 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
General disorders
Pyrexia
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/64 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
11.1%
6/54 • Number of events 8 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Investigations
Haemoglobin decreased
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
11.1%
6/54 • Number of events 11 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Investigations
Neutrophil count decreased
|
6.2%
4/64 • Number of events 11 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
18.5%
10/54 • Number of events 22 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Investigations
Platelet count decreased
|
6.2%
4/64 • Number of events 9 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
18.5%
10/54 • Number of events 16 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Nervous system disorders
Dysgeusia
|
4.7%
3/64 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
13.0%
7/54 • Number of events 9 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Nervous system disorders
Headache
|
12.5%
8/64 • Number of events 12 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
11.1%
6/54 • Number of events 8 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Nervous system disorders
Paraesthesia
|
4.7%
3/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Psychiatric disorders
Sleep disorder
|
6.2%
4/64 • Number of events 6 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
6/64 • Number of events 7 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
29.6%
16/54 • Number of events 19 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.9%
7/64 • Number of events 8 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
16.7%
9/54 • Number of events 10 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
2/64 • Number of events 2 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 6 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
4/64 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
9.3%
5/54 • Number of events 5 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/64 • Number of events 1 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
5.6%
3/54 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
2/64 • Number of events 3 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
7.4%
4/54 • Number of events 4 • baseline through four 21-day cycles and up to 30 days of follow-up after last infusion
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60