Status:
COMPLETED
Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Far Eastern Memorial Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (\~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with...
Detailed Description
1. To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed gastric adenocarcinoma
- Measurable or evaluable disease
- No previous C/T
- Age 16 \~ 75 years
- Karnofsky Performance Status of 60%
- 4 weeks after R/T
- Adjuvant C/T: the last dosing of C/T 6 months before enrollment
- WBC \>= 4,000, platelets \>= 100K, Creatinine \<= 1.5mg/dl and proteinuria \<1+, normal serum bil, transaminase \<= 3.5x ULN, TG \> 70mg/dl
Exclusion
- CNS metastasis
- Patients receive concomitant anti-cancer C/T or R/T
- Patients who are pregnant and with an expected life expectancy less than 3 months
- Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00166881
Start Date
June 1 2000
End Date
June 1 2011
Last Update
July 8 2013
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100