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

September 13, 2005
April 19, 2006
January 2005
Not Provided
Incidence and severity of adverse event
Same as current
Complete list of historical versions of study NCT00209703 on ClinicalTrials.gov Archive Site
Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Oxaliplatin
  • Drug: l-Leucovorin
  • Drug: 5-Fluorouracil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
June 2007
Not Provided

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.
Both
15 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00209703
HGCSG0501
Not Provided
Not Provided
Hokkaido Gastrointestinal Cancer Study Group
Not Provided
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP