Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil/Leucovorin for Non-Resectable Gastric Cancers
16 Years
75 Years
Both
Gastric Cancer
Trial Information
Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil/Leucovorin for Non-Resectable Gastric Cancers
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 by P-HDFL regimen
2. To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen
for those patients who have either failed to achieve remission or have recurred from
P-HDFL chemotherapy
3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule
for gastric cancer patients
4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric
cancers
Inclusion Criteria:
1. Histologically or cytologically confirmed gastric adenocarcinoma
2. Measurable or evaluable disease
3. No previous C/T
4. Age 16 ~ 75 years
5. Karnofsky Performance Status of 60%
6. 4 weeks after R/T
7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment
8. WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal
serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl
Exclusion Criteria:
1. CNS metastasis
2. Patients receive concomitant anti-cancer C/T or R/T
3. Patients who are pregnant and with an expected life expectancy less than 3 months
4. Symptomatic heart disease, active infection, extensive liver disease, or liver
cirrhosis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival (OS)
Outcome Time Frame:
Five years
Safety Issue:
No
Principal Investigator
Ann-Lii Cheng, M.D.,Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Oncology, National Taiwan University Hospital
Authority:
Taiwan: Department of Health
Study ID:
57M9
NCT ID:
NCT00166881
Start Date:
June 2000
Completion Date:
March 2009
Related Keywords:
- Gastric Cancer
- Combination, Chemotherapy, Inoperable Gastric Cancer
- Stomach Neoplasms
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