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

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Docetaxel-Irinotecan

• Registration Number: NCT00166881
• Lead Sponsor: National Taiwan University Hospital

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 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.

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 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

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2012-11
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, 2, III	Docetaxel-Irinotecan	Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Five years

Secondary Outcome Measures

Name	Time	Method
Objective response rates (CR, PR)	Confirmed objective response after 4 weeks

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan