Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Stomach Cancer

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

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)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

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
Health Authority:	United States: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA)

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 September 23, 2016