Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer - Full Text View

Sponsored by:	Hokkaido Gastrointestinal Cancer Study Group
Information provided by:	Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00209703

Purpose

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

Condition	Intervention	Phase
Colorectal Cancer	Drug: Oxaliplatin Drug: l-Leucovorin Drug: 5-Fluorouracil	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:

Incidence and severity of adverse event

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	15 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209703

Locations

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

Sponsors and Collaborators

Hokkaido Gastrointestinal Cancer Study Group

Investigators

Study Chair:

Masahiro Asaka, MD, PhD

Hokkaido Gastrointestinal Cancer Study Group

More Information

Study ID Numbers:	HGCSG0501
Study First Received:	September 13, 2005
Last Updated:	April 19, 2006
ClinicalTrials.gov Identifier:	NCT00209703
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases

Leucovorin
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009