Status:
UNKNOWN
Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborating Sponsors:
Hokkaido University Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 postop...
Detailed Description
A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st li...
Eligibility Criteria
Inclusion
- Histological diagnosis of colorectal adenocarcinoma.
- Measurable or assessable lesions.
- Age: 18 \~ 75 years.
- Performance Status (ECOG): 0 \~ 2.
- 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.
- No history of treatment with CPT-11 or S-1.
- No history of radiotherapy to the abdomen.
- Oral intake of S-1 is possible.
- 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).
- Predicted survival for \>3 months.
- Able to give written informed consent
Exclusion
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Diarrhea (watery stools).
- Uncontrolled ischemic heart disease.
- Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Active multiple cancer.
- Severe mental disorder.
- Pregnancy, possible pregnancy, or breast-feeding.
- Flucytosine treatment
- Gilbert's syndrome (4).
- Judged to be ineligible for this protocol by the attending physician.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00209651
Start Date
January 1 2004
End Date
December 1 2007
Last Update
November 1 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638