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Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
This study has been terminated.
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209703
First received: September 13, 2005
Last updated: April 19, 2006
Last verified: April 2006
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Purpose
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
| Condition | Intervention | Phase |
|---|---|---|
| Colorectal Cancer | Drug: Oxaliplatin Drug: l-Leucovorin Drug: 5-Fluorouracil | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:
Primary Outcome Measures:
- Incidence and severity of adverse event
Secondary Outcome Measures:
- Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 75 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00209703
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209703
Locations
| Japan | |
| Hokkaido University Hospital (Hokkaido University Graduate School of Medicine) | |
| Sapporo, Hokkaido, Japan, 060-8638 | |
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Investigators
| Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
More Information
| ClinicalTrials.gov Identifier: | NCT00209703 History of Changes |
| Other Study ID Numbers: |
HGCSG0501 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 19, 2006 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin |
Fluorouracil Levoleucovorin Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents |
ClinicalTrials.gov processed this record on July 27, 2017