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Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190801
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. Pemetrexed has shown synergy with cisplatin in preclinical models and in various human cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The patients, who will give their consent for participating in this study, will be screened for their eligibility and on meeting pre-defined study eligibility criteria, they will receive an intravenous therapy of the combination of pemetrexed and cisplatin for number of times that in the opinion of their treating physician is appropriate for them. A response rate of 30% is considered as the minimum activity level of interest for this patient population.
| Condition | Intervention | Phase |
|---|---|---|
| Gastrointestinal Neoplasms | Drug: pemetrexed Drug: cisplatin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Open-Label Single-Arm Phase 2 Study of ALIMTA Plus Cisplatin in Korean Patients With Advanced Gastric Carcinoma |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Response rate according to RECIST criteria
Secondary Outcome Measures:
- The following time to event efficacy measures:
- o Duration of overall response for responding patients
- o Time to documented progressive disease
- o Time to treatment failure
- o Overall survival
- The quantitative and qualitative toxicity of pemetrexed plus cisplatin in this patient population
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | September 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 RECIST criteria
- Performance Status of 0 or 1 on the ECOG Scale and adequate organ function.
- Signed informed consent from patient
Exclusion Criteria:
- Prior palliative chemotherapy for advanced disease.
- Known or suspected brain metastasis or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Concurrent administration of any other tumor therapy
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA plus cisplatin.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190801
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190801
Locations
| Korea, Republic of | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Goyang-Si, Korea, Republic of | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| In Cheon, Korea, Republic of | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| ClinicalTrials.gov Identifier: | NCT00190801 History of Changes |
| Other Study ID Numbers: |
6154 H3E-KL-JMFK |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
Additional relevant MeSH terms:
|
Gastrointestinal Neoplasms Digestive System Neoplasms Stomach Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017