Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00209703 |
Recruitment Status
:
Terminated
First Posted
: September 21, 2005
Last Update Posted
: April 21, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: Oxaliplatin Drug: l-Leucovorin Drug: 5-Fluorouracil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2005 |
Study Completion Date : | June 2007 |

- Incidence and severity of adverse event
- Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)

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Ages Eligible for Study: | 15 Years to 75 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209703
Japan | |
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine) | |
Sapporo, Hokkaido, Japan, 060-8638 |
Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209703 History of Changes |
Other Study ID Numbers: |
HGCSG0501 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | April 21, 2006 |
Last Verified: | April 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 |