Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
P-HDFL-DI
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 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started Jun 2000
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 8, 2013
November 1, 2012
10.5 years
September 12, 2005
July 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Five years
Secondary Outcomes (1)
Objective response rates (CR, PR)
Confirmed objective response after 4 weeks
Study Arms (1)
A, 2, III
EXPERIMENTALWeekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
Interventions
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed gastric adenocarcinoma
- Measurable or evaluable disease
- No previous C/T
- Age 16 \~ 75 years
- Karnofsky Performance Status of 60%
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Far Eastern Memorial Hospitalcollaborator
Study Sites (1)
Department of Oncology, National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ann-Lii Cheng, M.D.,Ph.D.
Department of Oncology, National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
June 1, 2000
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
July 8, 2013
Record last verified: 2012-11