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Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma

Primary Purpose

Gastrointestinal Neoplasms

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pemetrexed
cisplatin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.
  • 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.
  • 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.

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00190801
Brief Title
Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
Official Title
Open-Label Single-Arm Phase 2 Study of ALIMTA Plus Cisplatin in Korean Patients With Advanced Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Type
Drug
Intervention Name(s)
cisplatin
Primary Outcome Measure Information:
Title
Response rate according to RECIST criteria
Secondary Outcome Measure Information:
Title
The following time to event efficacy measures:
Title
o Duration of overall response for responding patients
Title
o Time to documented progressive disease
Title
o Time to treatment failure
Title
o Overall survival
Title
The quantitative and qualitative toxicity of pemetrexed plus cisplatin in this patient population

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Goyang-Si
Country
Korea, Republic of
Facility Name
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.
City
In Cheon
Country
Korea, Republic of
Facility Name
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.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma

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