Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Far Eastern Memorial Hospital
• Treatments: Camptothecin; Cisplatin; Docetaxel; Irinotecan

Criteria

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