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A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastases, Colorectal Neoplasms, Colorectal Carcinoma

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Trial Information

A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)


Inclusion Criteria:



- Histologically or cytologically proven adenocarcinoma of the colon or the rectum

- age > 18 years

- WHO performance status : 0,1,2

- Signed written informed consent prior to study entry

- Disease stage : metastatic disease not amenable to potentially curative treatment (eg
: inoperable metastatic disease)

- Measurable disease

- No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant
chemotherapy allowed (disease free interval from end of adjuvant therapy of at least
6 months)

- Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and
if not administered to target lesions identified for the study

Exclusion Criteria:

- Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant
therapy

- Prior therapy with Oxaliplatin

- History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within
the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency

- History of intolerance to appropriate antiemetics

- Concurrent active cancer originating from a primary site other than colon or rectum

- Presence of any symptom suggesting brain metastasis

- Known peripheral neuropathy

- Interstitial pneumonia or extensive and symptomatic fibrosis of the lung

- Allergy to Xaliproden/excipients

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W

Principal Investigator

Gérard SAID, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hôpital de Bicêtre - Le Kremlin-Bicêtre - France

Authority:

United Kingdom: National Health Service

Study ID:

EFC4972

NCT ID:

NCT00272051

Start Date:

July 2002

Completion Date:

May 2004

Related Keywords:

  • Metastases
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Neurotoxicity syndromes
  • Paresthesia
  • Oxaliplatin
  • Xaliproden
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neurotoxicity Syndromes

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