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Completed

NCT Number: NCT00190801

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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., Goyang-si, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pemetrexed

Drug

Cisplatin

Drug

Primary outcomes

  1. Response rate according to RECIST criteria

Secondary outcomes

  1. The following time to event efficacy measures:

  2. o Duration of overall response for responding patients

  3. o Time to documented progressive disease

  4. o Time to treatment failure

  5. o Overall survival

  6. The quantitative and qualitative toxicity of pemetrexed plus cisplatin in this patient population

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Open-Label Single-Arm Phase 2 Study of ALIMTA Plus Cisplatin in Korean Patients With Advanced Gastric Carcinoma

Important dates

Study start
2003
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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