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Oxaliplatin in Rectal Cancer

This study has been terminated.
(Study cancelled because recruitment rate was too slow)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00259363
First received: November 28, 2005
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Sanofi:

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:
    Drug: Oxaliplatin
    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
Investigators
Study Director: José Mª Taboada Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00259363     History of Changes
Other Study ID Numbers: L_8330
Study First Received: November 28, 2005
Last Updated: December 4, 2009
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013