Oxaliplatin in Rectal Cancer - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00259363

Purpose

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.

Condition	Intervention	Phase
Rectal Neoplasms	Drug: Oxaliplatin	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Phase I : Maximum Tolerated Dose & Recommended Dose [ Time Frame: Days 1, 15, 29 ] [ Designated as safety issue: No ]
Phase II : Response and resectability rate. [ Time Frame: 6 cycles in 6 months ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	October 2002
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259363

Locations

Spain
Sanofi-Aventis
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

José Mª Taboada

Sanofi-Aventis

More Information

Study results This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_8330
Study First Received:	November 28, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00259363
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm

Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009