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

NCT00316745 | Suspended Phase 3 DMC

• 2 other identifiers: HGCSG0601IFOX study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Colorectal Cancer

Keywords

irinotecan; S-1; Oxaliplatin; l-leucovorin; Fluorouracil; Metastatic colorectal cancer; phase III

Outcome Measures

Primary Outcomes (1)

• PFS of 1st line treatment

  2-years

Secondary Outcomes (4)

• OS

  4-years

• objective tumor response

  1-year

• PFS of 2nd line treatment

  1-year

• safety

  4-years

Study Arms (2)

1

ACTIVE COMPARATOR

mFOLFOX6 （ → IRIS ( Irinotecan and S-1) ）

Drug: L-Plat; Drug: Isovorin; Drug: 5-FU

2

EXPERIMENTAL

IRIS ( Irinotecan and S-1 ) → mFOLFOX6

Drug: Campto, Topotesin; Drug: TS-1

Interventions

Campto, Topotesin DRUG

100 mg/m2, IV (in the vein) on day 1,15 of each cycle.

Also known as: Irinotecan

2

TS-1 DRUG

S-1 Day1\~14, everyday P.O.(Day 15\~28 rest)

Also known as: S-1

2

L-Plat DRUG

Oxaliplatin (85mg/m2) Day 1, 15

Also known as: Oxaliplatin

1

Isovorin DRUG

l-leucovorin (200mg/m2) Day 1, 15

Also known as: l-leucovorin

1

5-FU DRUG

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.

Also known as: Fluorouracil

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
• Patients can not have oral intake
• Patients receiving Flucytosine treatment
• Patients with severe pleural effusion or ascites.
• Patients who have brown brain metastasis
• Patients with diarrhea 4 or more times per day
• Patients with active gastrointestinal bleeding.
• Patients with intestinal obstruction
• Patients with active infection.
• Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
• 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).
• Patients with significant cardiac disease.
• Patients with active multiple cancer.
• Patients with neuropathy ≥ grade 2
• Patients who are pregnant, are of childbearing potential, or breast-feeding.

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead
• Hokkaido University Hospital: collaborator

Study Sites (1)

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; titanium silicide; S 1 (combination); Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yoshito Komatsu, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: April 1, 2006
• Study Completion: March 1, 2009
• Last Updated: November 1, 2007

Record last verified: 2007-10

Locations

JP (1)