|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00320515 |
|
Date of registration:
|
28/04/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
|
|
Scientific title:
|
Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma. |
|
Date of first enrolment:
|
March 2004 |
|
Target sample size:
|
89 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00320515 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Argentina
|
Korea, Republic of
|
Mexico
|
Taiwan
| | | | |
|
Contacts
|
|
Name:
|
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Eli Lilly and Company |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Histological proven diagnosis of adenocarcinoma of the stomach
- Stage IV disease not amenable to curative surgery.
- Disease status must be that of measurable disease as defined by Response Evaluation
Criteria In Solid Tumors (RECIST) criteria.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.
- Adequate organ functions
Exclusion Criteria:
- Prior palliative chemotherapy for advanced gastric cancer.
- Pregnancy and breast feeding.
- Known or suspected brain metastasis and secondary primary malignancy
- Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a
5-day period.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- Concurrent administration of any other tumor therapy.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Neoplasm, Gastric
|
|
Intervention(s)
|
|
Drug: cisplatin
|
|
Drug: pemetrexed
|
|
Primary Outcome(s)
|
|
Objective Best Tumor Response
[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)]
|
|
Secondary Outcome(s)
|
|
Duration of Response
[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)]
|
|
Overall Survival
[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)]
|
|
Progression Free Survival
[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)]
|
|
Secondary ID(s)
|
|
7461
|
|
H3E-AA-S038
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|