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Oxaliplatin in Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Phase I : Maximum Tolerated Dose & Recommended Dose
Phase II : Response and resectability rate.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2005
Last Updated
December 4, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00259363
Brief Title
Oxaliplatin in Rectal Cancer
Official Title
Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Study cancelled because recruitment rate was too slow
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
Primary Outcome Measure Information:
Title
Phase I : Maximum Tolerated Dose & Recommended Dose
Time Frame
Days 1, 15, 29
Title
Phase II : Response and resectability rate.
Time Frame
6 cycles in 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Mª Taboada
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain

12. IPD Sharing Statement

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Oxaliplatin in Rectal Cancer

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