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

Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00209651
• Other study ID #: HGCSG0302
• Secondary ID: IRIS
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 31, 2007
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: October 2007
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Campto, Topotesin
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
• TS-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group	Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective tumor response		1-year
Secondary	Response duration, time to progression, overall survival, and safety will also be assessed.		2-years