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Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin (P-HDFL-DI)

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ClinicalTrials.gov Identifier: NCT00166881
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : July 8, 2013
Far Eastern Memorial Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel-Irinotecan Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2000
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A, 2, III
Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
Drug: Docetaxel-Irinotecan
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
Other Names:
  • Docetaxel (taxotere)
  • Irinotecan (campto, CPT-11)

Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Objective response rates (CR, PR) [ Time Frame: Confirmed objective response after 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166881

Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Study Chair: Ann-Lii Cheng, M.D.,Ph.D. Department of Oncology, National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00166881     History of Changes
Other Study ID Numbers: 57M9
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
Combination, Chemotherapy, Inoperable Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors