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Second-Line Irinotecan vs. ILF for AGC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00509964
First received: July 31, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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 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 Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • response rate

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 50
Study Start Date: May 2007
Estimated Study Completion Date: July 2007
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00509964     History of Changes
Other Study ID Numbers: GMO-GI-71
Study First Received: July 31, 2007
Last Updated: July 31, 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
Leucovorin
Irinotecan
Vitamin B Complex
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013