Trial Outcomes & Findings for Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer (NCT NCT00320515)
NCT ID: NCT00320515
Last Updated: 2009-09-28
Results Overview
Response 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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
COMPLETED
PHASE1/PHASE2
89 participants
baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
2009-09-28
Participant Flow
This was a Phase 1/2 trial. There were 16 participants in Phase 1. None of them qualified for the Phase 2 portion of the trial. There were 73 participants in Phase 2; however, 4 were excluded from all analyses due to data quality issues at one site. Results presented here are for the 69 participants in Phase 2.
Participant milestones
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Study
Death
|
33
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin
n=69 Participants
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Age Continuous
|
55.9 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
25 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0 - Fully Active
|
42 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
27 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
47 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
21 participants
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 disease progression, or up to 12 months after enrollment)Population: All enrolled participants who received at least one dose of study drug. One participant was excluded from analysis because of no measurable disease at baseline.
Response 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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=68 Participants
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Objective Best Tumor Response
Complete Response
|
1 participants
|
|
Objective Best Tumor Response
Partial Response
|
15 participants
|
|
Objective Best Tumor Response
Stable Disease
|
22 participants
|
|
Objective Best Tumor Response
Progressive Disease
|
24 participants
|
|
Objective Best Tumor Response
Unknown
|
6 participants
|
SECONDARY outcome
Timeframe: time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)Population: All enrolled participants who received at least one dose of study drug, had measureable disease at baseline, and had confirmed complete or partial responses. There were 16 patients qualified for the analysis of duration of response. Twelve participants were censored.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=16 Participants
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Duration of Response
|
5.4 months
Interval 4.6 to 6.9
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)Population: All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.
The period from study entry until disease progression or death on study, whichever occurred first.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=68 Participants
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Progression Free Survival
|
4.9 months
Interval 2.8 to 7.1
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)Population: All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.
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 + Cisplatin
n=68 Participants
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Overall Survival
|
11.8 months
Interval 7.2 to 18.5
|
Adverse Events
Pemetrexed + Cisplatin
Serious adverse events
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
2.9%
2/69 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.9%
2/69 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.4%
1/69 • Number of events 1
|
|
Nervous system disorders
Central nervous system lesion
|
1.4%
1/69 • Number of events 1
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
1.4%
1/69 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/69 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
1.4%
1/69 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/69 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/69 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/69 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.4%
1/69 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin
Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
13/69 • Number of events 24
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.7%
6/69 • Number of events 9
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.4%
12/69 • Number of events 18
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.9%
22/69 • Number of events 43
|
|
Gastrointestinal disorders
Abdominal distension
|
11.6%
8/69 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
13/69 • Number of events 14
|
|
Gastrointestinal disorders
Constipation
|
34.8%
24/69 • Number of events 32
|
|
Gastrointestinal disorders
Diarrhoea
|
23.2%
16/69 • Number of events 24
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
4/69 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
53.6%
37/69 • Number of events 89
|
|
Gastrointestinal disorders
Stomatitis
|
5.8%
4/69 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
37.7%
26/69 • Number of events 51
|
|
General disorders
Asthenia
|
8.7%
6/69 • Number of events 6
|
|
General disorders
Fatigue
|
42.0%
29/69 • Number of events 52
|
|
General disorders
Mucosal inflammation
|
5.8%
4/69 • Number of events 6
|
|
General disorders
Oedema
|
7.2%
5/69 • Number of events 5
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
6/69 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
8/69 • Number of events 9
|
|
Investigations
Blood alkaline phosphatase increased
|
17.4%
12/69 • Number of events 17
|
|
Investigations
Blood bilirubin increased
|
5.8%
4/69 • Number of events 4
|
|
Investigations
Blood creatinine increased
|
10.1%
7/69 • Number of events 18
|
|
Investigations
Creatinine renal clearance decreased
|
5.8%
4/69 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
43.5%
30/69 • Number of events 45
|
|
Investigations
Neutrophil count decreased
|
37.7%
26/69 • Number of events 65
|
|
Investigations
Platelet count decreased
|
15.9%
11/69 • Number of events 21
|
|
Investigations
Weight decreased
|
14.5%
10/69 • Number of events 11
|
|
Investigations
White blood cell count decreased
|
26.1%
18/69 • Number of events 27
|
|
Metabolism and nutrition disorders
Anorexia
|
39.1%
27/69 • Number of events 56
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
6/69 • Number of events 7
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.8%
4/69 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.2%
5/69 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.3%
14/69 • Number of events 30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.9%
11/69 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.0%
9/69 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
4/69 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.2%
5/69 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.8%
13/69 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
7/69 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
6/69 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
14.5%
10/69 • Number of events 19
|
|
Nervous system disorders
Headache
|
14.5%
10/69 • Number of events 14
|
|
Nervous system disorders
Hypoaesthesia
|
10.1%
7/69 • Number of events 7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.7%
6/69 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
13.0%
9/69 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
11/69 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
8/69 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.0%
9/69 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.8%
4/69 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
14.5%
10/69 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.1%
7/69 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.1%
7/69 • Number of events 7
|
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