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Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00320515
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasm, Gastric
Interventions Drug: pemetrexed
Drug: cisplatin
Enrollment 89
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
Period Title: Overall Study
Started 69
Completed 20
Not Completed 49
Reason Not Completed
Death             33
Lost to Follow-up             6
Physician Decision             2
Withdrawal by Subject             8
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description 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 Number of Baseline Participants 69
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants
55.9  (10.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
Female
20
  29.0%
Male
49
  71.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants
Taiwan 22
Mexico 4
Argentina 18
Korea, Republic of 25
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants
0 - Fully Active 42
1 - Ambulatory, Restricted Strenuous Activity 27
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants
Caucasian 1
East Asian 47
Hispanic 21
1.Primary Outcome
Title Objective Best Tumor Response
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: participants
Complete Response 1
Partial Response 15
Stable Disease 22
Progressive Disease 24
Unknown 6
2.Secondary Outcome
Title Duration of Response
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: months
5.4
(4.6 to 6.9)
3.Secondary Outcome
Title Progression Free Survival
Hide Description The period from study entry until disease progression or death on study, whichever occurred first.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(2.8 to 7.1)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Median (95% Confidence Interval)
Unit of Measure: months
11.8
(7.2 to 18.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
All-Cause Mortality
Pemetrexed + Cisplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   14    
Blood and lymphatic system disorders   
Neutropenia  1  1/69 (1.45%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/69 (1.45%)  1
Abdominal pain upper  1  1/69 (1.45%)  1
Ascites  1  1/69 (1.45%)  1
Colonic obstruction  1  1/69 (1.45%)  1
Ileus  1  2/69 (2.90%)  2
Upper gastrointestinal haemorrhage  1  2/69 (2.90%)  2
Vomiting  1  1/69 (1.45%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/69 (1.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour haemorrhage  1  1/69 (1.45%)  1
Nervous system disorders   
Central nervous system lesion  1  1/69 (1.45%)  1
Ischaemic cerebral infarction  1  1/69 (1.45%)  1
Renal and urinary disorders   
Renal failure  1  1/69 (1.45%)  1
Respiratory, thoracic and mediastinal disorders   
Asthmatic crisis  1  1/69 (1.45%)  1
Dyspnoea  1  1/69 (1.45%)  1
Pulmonary embolism  1  1/69 (1.45%)  1
Vascular disorders   
Deep vein thrombosis  1  1/69 (1.45%)  1
Hypotension  1  1/69 (1.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   69    
Blood and lymphatic system disorders   
Anaemia  1  13/69 (18.84%)  24
Leukopenia  1  6/69 (8.70%)  9
Lymphopenia  1  12/69 (17.39%)  18
Neutropenia  1  22/69 (31.88%)  43
Gastrointestinal disorders   
Abdominal distension  1  8/69 (11.59%)  9
Abdominal pain  1  13/69 (18.84%)  14
Constipation  1  24/69 (34.78%)  32
Diarrhoea  1  16/69 (23.19%)  24
Dyspepsia  1  4/69 (5.80%)  4
Nausea  1  37/69 (53.62%)  89
Stomatitis  1  4/69 (5.80%)  7
Vomiting  1  26/69 (37.68%)  51
General disorders   
Asthenia  1  6/69 (8.70%)  6
Fatigue  1  29/69 (42.03%)  52
Mucosal inflammation  1  4/69 (5.80%)  6
Oedema  1  5/69 (7.25%)  5
Investigations   
Alanine aminotransferase increased  1  6/69 (8.70%)  6
Aspartate aminotransferase increased  1  8/69 (11.59%)  9
Blood alkaline phosphatase increased  1  12/69 (17.39%)  17
Blood bilirubin increased  1  4/69 (5.80%)  4
Blood creatinine increased  1  7/69 (10.14%)  18
Creatinine renal clearance decreased  1  4/69 (5.80%)  4
Haemoglobin decreased  1  30/69 (43.48%)  45
Neutrophil count decreased  1  26/69 (37.68%)  65
Platelet count decreased  1  11/69 (15.94%)  21
Weight decreased  1  10/69 (14.49%)  11
White blood cell count decreased  1  18/69 (26.09%)  27
Metabolism and nutrition disorders   
Anorexia  1  27/69 (39.13%)  56
Decreased appetite  1  6/69 (8.70%)  7
Diabetes mellitus  1  4/69 (5.80%)  4
Hypercholesterolaemia  1  5/69 (7.25%)  12
Hyperglycaemia  1  14/69 (20.29%)  30
Hyperkalaemia  1  11/69 (15.94%)  14
Hypocalcaemia  1  9/69 (13.04%)  19
Hypokalaemia  1  4/69 (5.80%)  7
Hypomagnesaemia  1  5/69 (7.25%)  5
Hyponatraemia  1  13/69 (18.84%)  15
Musculoskeletal and connective tissue disorders   
Back pain  1  7/69 (10.14%)  7
Myalgia  1  6/69 (8.70%)  8
Nervous system disorders   
Dizziness  1  10/69 (14.49%)  19
Headache  1  10/69 (14.49%)  14
Hypoaesthesia  1  7/69 (10.14%)  7
Peripheral sensory neuropathy  1  6/69 (8.70%)  6
Psychiatric disorders   
Insomnia  1  9/69 (13.04%)  9
Respiratory, thoracic and mediastinal disorders   
Cough  1  11/69 (15.94%)  13
Dyspnoea  1  8/69 (11.59%)  8
Hiccups  1  9/69 (13.04%)  10
Rhinorrhoea  1  4/69 (5.80%)  4
Skin and subcutaneous tissue disorders   
Pigmentation disorder  1  10/69 (14.49%)  10
Pruritus  1  7/69 (10.14%)  9
Rash  1  7/69 (10.14%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00320515    
Other Study ID Numbers: 7461
H3E-AA-S038
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: July 9, 2009
Results First Posted: September 28, 2009
Last Update Posted: September 28, 2009