Trial | NCT00166881  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    29
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.
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
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
To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers
Study Started
Jun 30
2000
Primary Completion
Dec 31
2010
Study Completion
Jun 30
2011
Last Update
Jul 08
2013
Estimate

Drug Docetaxel-Irinotecan

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

  • Other names: Docetaxel (taxotere), Irinotecan (campto, CPT-11)

A, 2, III Experimental

Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL

Criteria 

Inclusion Criteria:

Histologically or cytologically confirmed gastric adenocarcinoma
Measurable or evaluable disease
No previous C/T
Age 16 ~ 75 years
Karnofsky Performance Status of 60%
4 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

Exclusion Criteria:

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
No Results Posted