Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00209703
• Other study ID #: HGCSG0501
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 19, 2006
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: April 2006
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Oxaliplatin

• l-Leucovorin

• 5-Fluorouracil

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse event
Secondary	Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)