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Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Oxaliplatin
l-Leucovorin
5-Fluorouracil
Sponsored by
Hokkaido Gastrointestinal Cancer Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histological diagnosis of colorectral adenocarcinoma. Measurable or assessable lesions. Age: 15 ~ 75 years. Performance Status (ECOG): 0 ~ 2. Prior chemotherapy within 2 regimens. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/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 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for >8 weeks. (11) 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. 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. Patients with neuropathy ≥ grade 2 Judged to be ineligible for this protocol by the attending physician.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Incidence and severity of adverse event

Secondary Outcome Measures

Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)

Full Information

First Posted
September 13, 2005
Last Updated
April 19, 2006
Sponsor
Hokkaido Gastrointestinal Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00209703
Brief Title
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
Official Title
Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Terminated
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hokkaido Gastrointestinal Cancer Study Group

4. Oversight

5. Study Description

Brief Summary
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
Detailed Description
A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
l-Leucovorin
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Primary Outcome Measure Information:
Title
Incidence and severity of adverse event
Secondary Outcome Measure Information:
Title
Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological diagnosis of colorectral adenocarcinoma. Measurable or assessable lesions. Age: 15 ~ 75 years. Performance Status (ECOG): 0 ~ 2. Prior chemotherapy within 2 regimens. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/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 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for >8 weeks. (11) 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. 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. Patients with neuropathy ≥ grade 2 Judged to be ineligible for this protocol by the attending physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiro Asaka, MD, PhD
Organizational Affiliation
Hokkaido Gastrointestinal Cancer Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

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