Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment

Outcome Time Frame:

Q2W during treatment, Q4W to Q12W during post-treatment follow-up

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC5505

NCT ID:

NCT00305188

Start Date:

December 2005

Completion Date:

October 2009

Related Keywords:

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

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807