Oxaliplatin in Rectal Cancer

December 4, 2009 updated by: Sanofi

Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
Phase II: To determine the treatment efficacy according to response rates from phase I.

Study Overview

Status

Terminated

Conditions

Rectal Neoplasms

Intervention / Treatment

Drug: Oxaliplatin

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

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

Spain
- - Barcelona, Spain
    - 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

ECOG: 0-2
Histological proved rectal adenocarcinoma
No chemotherapy treatment on the previous 6 months before inclusion.
No previous pelvic radiotherapy treatment

Exclusion Criteria:

Important Biological abnormality (renal, hepatic and/or hematological)
Intestinal occlusion or subocclusion
Peripheral neuropathy
Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
Participation in other trials on the previous 4 months.

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
Phase I : Maximum Tolerated Dose & Recommended Dose Time Frame: Days 1, 15, 29	Days 1, 15, 29
Phase II : Response and resectability rate. Time Frame: 6 cycles in 6 months	6 cycles in 6 months

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

Study Director: JOSÉ Mª TABOADA, 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

October 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria