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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209703

Enrollment

Registered

2005-09-21

Start date

2005-01-31

Completion date

2007-06-30

Last updated

2006-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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 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.

Interventions

DRUGOxaliplatin

DRUGl-Leucovorin

DRUG5-Fluorouracil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse event	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026