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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166881

Acronym

P-HDFL-DI

Enrollment

Registered

2005-09-14

Start date

2000-06-30

Completion date

2011-06-30

Last updated

2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Combination, Chemotherapy, Inoperable Gastric Cancer

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

Interventions

DRUGDocetaxel-Irinotecan

Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	Five years

Secondary

Measure	Time frame
Objective response rates (CR, PR)	Confirmed objective response after 4 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026