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Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

Sponsor
Hokkaido Gastrointestinal Cancer Study Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00209651
Collaborator
Hokkaido University Hospital (Other)
40
Enrollment
1
Location
1
Arm
47
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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 postoperative colorectal cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jan 1, 2004
Anticipated Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • irinotecan

    • Drug: TS-1
    80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
    Other Names:
  • S-1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. objective tumor response [1-year]

    Secondary Outcome Measures

    1. Response duration, time to progression, overall survival, and safety will also be assessed. [2-years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00209651
    Other Study ID Numbers:
    • HGCSG0302
    • IRIS
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Nov 1, 2007
    Last Verified:
    Oct 1, 2007
    Keywords provided by , ,
    Irinotecan, S-1, Phase II, colorectal cancer,
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Irinotecan

    Study Results

    No Results Posted as of Nov 1, 2007