IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00316745
• Other study ID #: HGCSG0601
• Secondary ID: IFOX study
• Status: Suspended
• Phase: Phase 3
• First received: April 19, 2006
• Last updated: October 31, 2007
• Start date: April 2006
• Est. completion date: March 2009

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

This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).

Description:

A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histological diagnosis of colorectal cancer. 2) Age: 18 - 75 years. 3) No prior chemotherapy 4) ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ?3,500/mm3 and Neutrophil ?2,000/mm3. Hb ?10.0 g/dl. Platelet count ?100,000/mm3. AST and ALT ?2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ?1.5 mg/dl. Creatinine ?1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.

Exclusion Criteria:

1. Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.

2. Patients can not have oral intake

3. Patients receiving Flucytosine treatment

4. Patients with severe pleural effusion or ascites.

5. Patients who have brown brain metastasis

6. Patients with diarrhea 4 or more times per day

7. Patients with active gastrointestinal bleeding.

8. Patients with intestinal obstruction

9. Patients with active infection.

10. Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)

11. Patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).

12. Patients with significant cardiac disease.

13. Patients with active multiple cancer.

14. Patients with neuropathy = grade 2

15. Patients who are pregnant, are of childbearing potential, or breast-feeding.

16. Patients with severe mental disorder.

17. Patients with a history of serious allergic reaction.

18. Judged to be ineligible for this protocol by the investigation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Campto, Topotesin
100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
• TS-1
S-1 Day1~14, everyday P.O.(Day 15~28 rest)
• L-Plat
Oxaliplatin (85mg/m2) Day 1, 15
• Isovorin
l-leucovorin (200mg/m2) Day 1, 15
• 5-FU
400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1~3 (48 hours) of each 28 day cycle.

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)	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	PFS of 1st line treatment		2-years
Secondary	OS		4-years
Secondary	objective tumor response		1-year
Secondary	PFS of 2nd line treatment		1-year
Secondary	safety		4-years