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Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209664
First received: September 13, 2005
Last updated: January 31, 2006
Last verified: January 2004

September 13, 2005
January 31, 2006
January 2004
Not Provided
objective tumor response
Same as current
Complete list of historical versions of study NCT00209664 on ClinicalTrials.gov Archive Site
Response duration, time to progression, median survival time, and safety will also be assessed.
Same as current
Not Provided
Not Provided
 
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative gastric cancer

A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: irinotecan
  • Drug: S-1
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
December 2008
Not Provided

Inclusion Criteria:

・ Eligibility criteria

  1. Histological diagnosis of gastric adenocarcinoma.
  2. Measurable or assessable lesions.
  3. Age: 18 ~ 75 years.
  4. Performance Status (ECOG): 0 ~ 2.
  5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
  6. No history of treatment with CPT-11 or S-1.
  7. No history of radiotherapy to the abdomen.
  8. Oral intake of S-1 is possible.
  9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for >3 months.

(11) Able to give written informed consent

Exclusion Criteria:

-

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00209664
HGCSG0303
Not Provided
Not Provided
Hokkaido Gastrointestinal Cancer Study Group
Not Provided
Study Chair: Yoshito Komatsu, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP