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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Gastrointestinal Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to RECIST criteria

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

6154

NCT ID:

NCT00190801

Start Date:

September 2003

Completion Date:

September 2005

Related Keywords:

  • Gastrointestinal Neoplasms
  • Neoplasms
  • Carcinoma
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Stomach Neoplasms

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