Status:
TERMINATED
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
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 reg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00209703
Start Date
January 1 2005
End Date
June 1 2007
Last Update
April 21 2006
Active Locations (1)
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1
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638