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
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Pemetrexed + Cisplatin | |
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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 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 69 participants | |
55.9 (10.20) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 69 participants | |
Female |
20 29.0%
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Male |
49 71.0%
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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).
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Race/Ethnicity
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 69 participants |
Caucasian | 1 | |
East Asian | 47 | |
Hispanic | 21 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | Eli Lilly and Company |
Phone: | 800-545-5979 |
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 |