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ILF With/Without Cisplatin for Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00320294
Recruitment Status : Unknown
Verified March 2007 by Gachon University Gil Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2006
Last Update Posted : March 12, 2007
Sponsor:
Information provided by:
Gachon University Gil Medical Center

Brief Summary:
To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Condition or disease Intervention/treatment Phase
Stomach Neoplasm Drug: irinotecan Drug: cisplatin Phase 2

Detailed Description:
Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen [Pozzo C, et al. Ann Oncol 2004]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Study Type : Interventional  (Clinical Trial)
Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study Start Date : February 2005
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  1. Objective response rate
  2. Safety

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Quality of life


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven gastric adenocarcinoma
  • Advanced, metastatic or recurrent
  • ECOG performance status 0 to 2
  • No prior chemotherapy
  • Measurable or evaluable indicator lesion(s)
  • Normal marrow, hepatic and renal functions
  • Provision of written informed consent

Exclusion Criteria:

  • Active infection, bleeding or severe comorbidities
  • Pregnant or breastfed women
  • Active CNS metastasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320294


Locations
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00320294     History of Changes
Other Study ID Numbers: GMO-GI-52
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: March 12, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Cisplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action