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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00436800 |
Purpose
Primary objective:
To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.
Secondary objectives:
To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.
| Condition | Intervention | Phase |
|
Nasopharyngeal Neoplasms |
Drug: Gemcitabine Drug: Oxaliplatin |
Phase II |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Oxaliplatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC) |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles.
|
Drug: Gemcitabine
1000mg/m² over 10mg/m²/min
Drug: Oxaliplatin
100 mg/m² over 2 hours.
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | L_9281 |
| First Received: | February 16, 2007 |
| Last Updated: | July 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00436800 |
| Health Authority: | Hong Kong: Department of Health |
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