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Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

This study has been terminated.
Sponsor:
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209703
First received: September 13, 2005
Last updated: April 19, 2006
Last verified: April 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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:

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

Locations
Japan
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

No publications provided

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013