Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00190801 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Neoplasms | Drug: pemetrexed Drug: cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 50 participants |
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 |
Study Start Date : | September 2003 |
Study Completion Date : | September 2005 |

- Response rate according to RECIST criteria
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190801
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00190801 |
Other Study ID Numbers: |
6154 H3E-KL-JMFK |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |