Oxaliplatin in Colonic Neoplasms - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Colonic Neoplasms

Intervention / Treatment

Drug: oxaliplatin

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China
    - Sanofi-Aventis
Hong Kong
- - Hong Kong, Hong Kong
    - Sanofi-Aventis
Korea, Republic of
- - Seoul, Korea, Republic of
    - Sanofi-Aventis
Taiwan
- - Taipei, Taiwan
    - Sanofi-Aventis
Thailand
- - Bangkok, Thailand
    - Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin).
Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
Patients must be entered in the study in order to start treatment within 7 weeks after surgery
Age 18-75 years old
Performance Status ≤ 2 (Karnofsky > or = 60%)
No previous chemotherapy, immunotherapy or radiotherapy
No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml.
Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
Signed informed consent obtained prior to study entry

Exclusion criteria

Pregnant or lactating women
Women of child bearing potential not using a contraceptive method
Previous cancer of the colon or rectum
Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
Participation in another clinical trial with any investigational drug within 30 days prior to randomization
Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I)
Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
History of significant neurologic or psychiatric disorders
Active infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of dose-limiting toxicity Time Frame: from the inform consent signed up to the end of the study	from the inform consent signed up to the end of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of one or more adverse event in a patient Time Frame: From the Informed Consent Form (ICF) signature to the end of the study	From the Informed Consent Form (ICF) signature to the end of the study
Overall distribution of intensity of adverse events Time Frame: from the inform consnet signed up to the end of the study	from the inform consnet signed up to the end of the study
Occurrence of particular adverse events and their intensities Time Frame: from the inform consent signed up to the end of the study	from the inform consent signed up to the end of the study
Percent of patients completing study treatment Time Frame: from the inform consent signed up to the end of the study	from the inform consent signed up to the end of the study
Percent of patients with grade 1, 2 and 3 neuropathy Time Frame: at 28 days, 6 months and 12 months after last chemotherapy administration.	at 28 days, 6 months and 12 months after last chemotherapy administration.
Percent of intended dose delivered for 5-FU/LV and Oxaliplatin Time Frame: from the informed consent signed up to the end of the study	from the informed consent signed up to the end of the study
Delays in scheduled dosing Time Frame: During the study conduct	During the study conduct
Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment Time Frame: during the study conduct	during the study conduct
•Survival Analysis •Laboratory assay and vital signs ECOG and KPS Time Frame: during the study conduct	during the study conduct
Long term toxicity Time Frame: during the study conduct	during the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

Study Director: Claude Valterio, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria