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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
Sponsor:
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin Drug: l-Leucovorin Drug: 5-Fluorouracil Phase 2

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 Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse event

Secondary Outcome Measures :
  1. Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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