ILF With/Without Cisplatin for Advanced Gastric Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasm |
Drug: irinotecan Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Objective response rate
- Safety
- Progression-free survival
- Overall survival
- Quality of life
| Estimated Enrollment: | 86 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | March 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| Gachon University Gil Medical Center | |
| Incheon, Korea, Republic of, 405 760 | |
| Principal Investigator: | Se Hoon Park, MD | Gachon University Gil Medical Center, Incheon, Korea |
More Information
No publications provided by Gachon University Gil Medical Center
Additional 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 |
| Study First Received: | May 1, 2006 |
| Last Updated: | March 9, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Irinotecan Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013