Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

NCT00209703 | Terminated Phase 2

• 1 other identifier: HGCSG0501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse event

Secondary Outcomes (1)

• Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)

Interventions

Oxaliplatin DRUG

l-Leucovorin DRUG

5-Fluorouracil DRUG

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead

Study Sites (1)

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Study Completion: June 1, 2007
• Last Updated: April 21, 2006

Record last verified: 2006-04

Locations

JP (1)