Clinical trial NCT00166881: Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Combination, Chemotherapy, Inoperable Gastric Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2005-09-14
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Five years
Secondary outcomes:
measure: Objective response rates (CR, PR)
timeFrame: Confirmed objective response after 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D.
role: STUDY_CHAIR
References: