Full Text View
Tabular View
No Study Results Posted
Related Studies
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
This study is ongoing, but not recruiting participants.
First Received: March 20, 2006   Last Updated: January 15, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00305188
  Purpose

Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.

Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.

Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS))

  • study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Condition Intervention Phase
Metastases
Colorectal Neoplasms
Colorectal Carcinoma
Drug: xaliproden (SR57746A)
Drug: Placebo
Drug: oxaliplatin
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Multicenter, Randomized Double-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-Line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment [ Time Frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Main: response rate using RECIST criteria [ Time Frame: Q8W ] [ Designated as safety issue: No ]
  • Other: nerve conduction studies [ Time Frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug ] [ Designated as safety issue: No ]
  • Other: progression free survival and survival [ Time Frame: Q8W and study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: December 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: xaliproden (SR57746A)
oral administration
Drug: oxaliplatin
in combination with 5-Fluorouracil and Leucovorin
2: Placebo Comparator Drug: Placebo
oral administration
Drug: oxaliplatin
in combination with 5-Fluorouracil and Leucovorin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main inclusion criteria :

  • Histologically or cytologically-proven metastatic cancer of the colon or rectum.
  • Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
  • Male or female aged >18 years.
  • WHO Performance Status (PS) : 0 or 1.
  • Measurable disease.
  • No prior chemotherapeutic regimen for metastatic disease.
  • Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
  • Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
  • Signed written informed consent prior to study entry.

Exclusion Criteria:

Main exclusion criteria :

  • Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
  • Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
  • Peripheral neuropathy >Grade 1.
  • Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
  • Concurrent active cancer originating from a primary site other than colon or rectum.
  • Presence of any symptom suggesting brain metastasis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305188

Locations
United States, Pennsylvania
Sanofi-aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Argentina
Sanofi-aventis Administrative Office
Buenos Aires, Argentina, 1642
Australia
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Brazil
Sanofi-aventis Administrative Office
Sao Paulo, Brazil, CEP 05677-000
Canada, Quebec
Sanofi-aventis Administrative Office
Laval, Quebec, Canada
Chile
Sanofi-aventis Administrative Office
Santiago, Chile
Germany
Sanofi-aventis Administrative Office
Berlin, Germany, D-10785
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary, H-1325
Italy
Sanofi-aventis Administrative Office
Milano, Italy, 20 158
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland, 02-672
Portugal
Sanofi-aventis Administrative Office
Porto Salvo, Portugal, 2740-244
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain, 08019
United Kingdom, Surrey
Sanofi-aventis Administrative Office
Guildford, Surrey, United Kingdom, GU1 4YS
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC5505, EUDRACT : 2005-002570-30
Study First Received: March 20, 2006
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00305188     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: National Health Service

Keywords provided by Sanofi-Aventis:
Neurotoxicity syndromes
Paresthesia
Oxaliplatin
Xaliproden

Study placed in the following topic categories:
Digestive System Neoplasms
Neurotoxicity Syndromes
Gastrointestinal Diseases
Colonic Diseases
Poisoning
Leucovorin
Disorders of Environmental Origin
Folinic Acid
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Digestive System Diseases
Fluorouracil
Paresthesia
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Disorders of Environmental Origin
Rectal Diseases
Neoplastic Processes
Oxaliplatin
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Poisoning
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 24, 2009