Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments campto, topotesin, ts-1
Phase phase 2
Sponsor Hokkaido Gastrointestinal Cancer Study Group
Collaborator Hokkaido University Hospital
Start date January 2004
End date December 2007
Trial size 40 participants
Trial identifier NCT00209651, HGCSG0302, IRIS

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 postoperative colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Irinotecan and S-1
campto, topotesin irinotecan
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
ts-1 S-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.

Primary Outcomes

Measure
objective tumor response
time frame: 1-year

Secondary Outcomes

Measure
Response duration, time to progression, overall survival, and safety will also be assessed.
time frame: 2-years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Histological diagnosis of colorectal 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: 1. Severe pleural effusion or ascites. 2. Metastasis to the central nervous system (CNS). 3. Active gastrointestinal bleeding. 4. Active infection. 5. Diarrhea (watery stools). 6. Uncontrolled ischemic heart disease. 7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. Active multiple cancer. 9. Severe mental disorder. 10. Pregnancy, possible pregnancy, or breast-feeding. 11. Flucytosine treatment 12. Gilbert's syndrome (4). 13. Judged to be ineligible for this protocol by the attending physician.

Additional Information

Official title Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302
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 line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Hokkaido Gastrointestinal Cancer Study Group.