Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

Phase 2

Terminated

• Conditions: Colorectal Cancer

• Registration Number: NCT00209703
• Lead Sponsor: Hokkaido Gastrointestinal Cancer Study Group

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2006-04
• Last Update Submitted: 2006-04-19
• Last Update Posted: 2006-04-21
• Study Completion: 2007-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse event

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine); 🇯🇵 Sapporo, Hokkaido, Japan