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| Sponsored by: |
Gachon University Gil Medical Center |
|---|---|
| Information provided by: | Gachon University Gil Medical Center |
| ClinicalTrials.gov Identifier: | NCT00509964 |
Purpose
Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available.
We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasm Metastatic Second-Line |
Drug: irinotecan Drug: ILF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
|
Drug: irinotecan
Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
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2: Active Comparator
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks.
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Drug: ILF
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.
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Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dong Bok Shin, MD, PhD | 82 32 460 3682 | dbs@gilhospital.com |
| Korea, Republic of | |
| Gachon University Gil Medical Center | Recruiting |
| Incheon, Korea, Republic of, 405 760 | |
| Contact: Se Hoon Park, MD +82 32 460 3682 hematoma@gilhospital.com | |
| Principal Investigator: | Se Hoon Park, MD | Gachon University Gil Medical Center, Incheon, Korea |
More Information
| Study ID Numbers: | GMO-GI-71 |
| Study First Received: | July 31, 2007 |
| Last Updated: | July 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00509964 |
| Health Authority: | Korea: Food and Drug Administration |
|
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Irinotecan Leucovorin Gastrointestinal Neoplasms Stomach cancer |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |
