Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
Inclusion Criteria:
- Histologically or cytologically confirmed gastric adenocarcinoma
- Received one prior regimen containing fluoropyrimidine analogs and developed disease
progression or recurrence
- Age: 20 - 74
- At least one measurable lesion by RECIST criteria
Exclusion Criteria:
- History of Taxans use
- Patients with another active malignancy
- Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
- Chronic treatment with steroids
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
During chemotherapy
Safety Issue:
No
Principal Investigator
Nagahiro Saijo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kinki University Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
Taiho10041040
NCT ID:
NCT00661167
Start Date:
April 2008
Completion Date:
December 2011
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
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