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Second-Line Irinotecan vs. ILF for AGC

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ClinicalTrials.gov Identifier: NCT00509964
Recruitment Status : Unknown
Verified July 2007 by Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
First Posted : August 1, 2007
Last Update Posted : August 1, 2007
Sponsor:
Information provided by:
Gachon University Gil Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Stomach Neoplasm Metastatic Second-Line Drug: irinotecan Drug: ILF Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
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.
Active Comparator: 2
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks.
Drug: ILF
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.



Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. safety


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

Inclusion Criteria:

  • histologically confirmed gastric cancer
  • inoperable, recurrent, or metastatic
  • performance status 0 to 2
  • failed after one or more prior chemotherapy for advanced disease
  • informed consent

Exclusion Criteria:

  • active infection
  • severe co-morbidities
  • previously treated with irinotecan or similar drugs

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): NCT00509964


Contacts
Contact: Dong Bok Shin, MD, PhD 82 32 460 3682 dbs@gilhospital.com

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

ClinicalTrials.gov Identifier: NCT00509964     History of Changes
Other Study ID Numbers: GMO-GI-71
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: August 1, 2007
Last Verified: July 2007

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