Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hokkaido Gastrointestinal Cancer Study Group.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209651
First received: September 13, 2005
Last updated: October 31, 2007
Last verified: October 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Campto, Topotesin Drug: TS-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302 |
Resource links provided by NLM:
Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:
Primary Outcome Measures:
- objective tumor response [ Time Frame: 1-year ]
Secondary Outcome Measures:
- Response duration, time to progression, overall survival, and safety will also be assessed. [ Time Frame: 2-years ]
| Enrollment: | 40 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Irinotecan and S-1
|
Drug: Campto, Topotesin
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
Other Name: irinotecan
Drug: TS-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
Other Name: S-1
|
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 line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209651
Locations
| Japan | |
| Hokkaido University Hospital | |
| Sapporo, Hokkaido, Japan, 060-8638 | |
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
| Study Chair: | Yoshito Komatsu, MD.PhD | Hokkaido Gastrointestinal Cancer Study Group |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00209651 History of Changes |
| Other Study ID Numbers: | HGCSG0302, IRIS |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 31, 2007 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
|
Irinotecan, S-1, Phase II, colorectal cancer, |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013