Trial Outcomes & Findings for Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer (NCT NCT00415168)
NCT ID: NCT00415168
Last Updated: 2010-08-17
Results Overview
Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.
COMPLETED
PHASE2
53 participants
Baseline to time of response up to six or eight 21-day cycles of treatment
2010-08-17
Participant Flow
56 participants signed informed consent and 3 participants were screen failures.
Participant milestones
| Measure |
Pemetrexed + Cisplatin
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
Completed Treatment
|
15
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Overall Study
Death
|
26
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Sponsor Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Age Continuous
|
54.3 years
STANDARD_DEVIATION 9.85 • n=99 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
53 participants
n=99 Participants
|
|
Region of Enrollment
Russian Federation
|
53 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
16 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
37 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to time of response up to six or eight 21-day cycles of treatmentPopulation: All patients enrolled in the study with a histologically confirmed diagnosis of adenocarcinoma of the gastric, disease status of measurable disease with presence of at least 1 measurable lesion, with no concurrent administration of any other tumor therapy or known or suspected brain metastasis who received at least 1 dose of study therapy.
Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Percentage of Participants With Objective Response (Objective Response Rate)
Responder
|
32.1 percentage of responders
Interval 19.9 to 46.3
|
|
Percentage of Participants With Objective Response (Objective Response Rate)
Non-Responder
|
67.9 percentage of responders
Interval 53.7 to 80.1
|
SECONDARY outcome
Timeframe: Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 monthsPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Duration of Response
|
3.8 months
Interval 3.3 to 4.7
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 monthsPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Progression Free Survival (PFS)
|
3.7 months
Interval 2.7 to 5.2
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 monthsPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Overall Survival
|
8.8 months
Interval 6.0 to 9.5
|
SECONDARY outcome
Timeframe: Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuationPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Any Grade 3 or 4 Laboratory Toxicity
|
29 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Bone/Blood Marrow - Other
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Lymphopenia
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Platelets
|
4 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Hemoglobin
|
6 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Leukocytes (Total White Blood Cells)
|
15 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Neutrophils/Granulocytes
|
29 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Uric Acid Serum-High
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy
Metabolic/Laboratory - Other
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuationPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Any Grade 3 or 4 Non-Laboratory Toxicity
|
5 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Anorexia
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Diarrhea
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Renal Failure
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Vomiting
|
1 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Nausea
|
2 participants
|
|
Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy
Fatigue
|
3 participants
|
SECONDARY outcome
Timeframe: During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 monthsPopulation: Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.
Outcome measures
| Measure |
Pemetrexed + Cisplatin
n=53 Participants
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Number of Participants Who Died During the Study
Pancytopenia
|
1 participants
|
|
Number of Participants Who Died During the Study
Study Disease
|
18 participants
|
|
Number of Participants Who Died During the Study
Cardiac Failure Acute
|
1 participants
|
|
Number of Participants Who Died During the Study
Death (General Disorders/Administration Site Cond)
|
1 participants
|
|
Number of Participants Who Died During the Study
Intestinal Hemorrhage
|
1 participants
|
|
Number of Participants Who Died During the Study
Sudden Death
|
3 participants
|
|
Number of Participants Who Died During the Study
Multi-Organ Failure
|
1 participants
|
Adverse Events
Pemetrexed + Cisplatin
Serious adverse events
| Measure |
Pemetrexed + Cisplatin
n=53 participants at risk
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.8%
2/53 • Number of events 2
|
|
Cardiac disorders
Cardiac failure acute
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
1/53 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Chest pain
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Death
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Multi-organ failure
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Sudden death
|
5.7%
3/53 • Number of events 3
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/53 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin
n=53 participants at risk
Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.9%
10/53 • Number of events 10
|
|
Blood and lymphatic system disorders
Leukopenia
|
24.5%
13/53 • Number of events 34
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.6%
30/53 • Number of events 67
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
5/53 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
4/53 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
26.4%
14/53 • Number of events 45
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
9/53 • Number of events 12
|
|
General disorders
Fatigue
|
24.5%
13/53 • Number of events 26
|
|
General disorders
Pyrexia
|
9.4%
5/53 • Number of events 5
|
|
Investigations
Creatinine renal clearance decreased
|
5.7%
3/53 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
18.9%
10/53 • Number of events 13
|
|
Investigations
Neutrophil count decreased
|
15.1%
8/53 • Number of events 14
|
|
Investigations
Platelet count decreased
|
15.1%
8/53 • Number of events 9
|
|
Investigations
Weight decreased
|
9.4%
5/53 • Number of events 5
|
|
Investigations
White blood cell count decreased
|
20.8%
11/53 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
3/53 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
3/53 • 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