Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: l-Leucovorin

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.

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8638
      • Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 15 ~ 75 years.
4. Performance Status (ECOG): 0 ~ 2.
5. Prior chemotherapy within 2 regimens.
6. 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:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Uncontrolled ischemic heart disease.
6. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
7. Active multiple cancer.
8. Severe mental disorder.
9. Pregnancy, possible pregnancy, or breast-feeding.
10. Patients with neuropathy ≥ grade 2
11. Judged to be ineligible for this protocol by the attending physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence and severity of adverse event

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Investigators: Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion: June 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): April 21, 2006
• Last Update Submitted That Met QC Criteria: April 19, 2006
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin; Levoleucovorin
• Other Study ID Numbers: HGCSG0501