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

NCT00190801 | Completed Phase 2

• 2 other identifiers: 6154H3E-KL-JMFK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Response rate according to RECIST criteria

Secondary Outcomes (6)

• 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

Interventions

pemetrexed DRUG

cisplatin DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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, South Korea

Location

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.

Incheon, South Korea

Location

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, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2003
• Study Completion: September 1, 2005
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

KR (3)