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Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 16, 2007
Last updated: September 17, 2009
Last verified: August 2009

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria [ Time Frame: Baseline to end of study ]
  • Safety: Clinical and laboratory criteria [ Time Frame: Baseline to end of study ]
  • The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Baseline to 30 days post treatment ]
  • Occurrence of serious adverse events (SAE) [ Time Frame: Baseline to 30 days post treatment ]
  • Drop-out rate [ Time Frame: End of study ]

Secondary Outcome Measures:
  • Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms. [ Time Frame: Baseline to end of study ]

Enrollment: 41
Study Start Date: March 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease.
  • Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin.
  • Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria)
  • Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment.
  • Eastern Cooperative Oncology Group performance status of 0-2
  • No serious, uncontrolled medical conditions that may be aggravated by treatment.
  • No other malignancy(s), except completely excised basal or squamous cell carcinoma of the skin, or completely treated carcinoma-in-situ of the cervix.
  • Adequate hematological function:absolute granulocyte count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L
  • Adequate renal and hepatic functions:·serum creatinine < 1.25 x upper normal limit (UNL) or a calculated creatinine clearance > 50 mL/min·serum bilirubin < 2 x UNL and Aspartate aminotransferase/Alanine aminotransferase < 3 x UNL

Exclusion Criteria:

  • Prior treatment with Oxaliplatin or Gemcitabine.
  • Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin.
  • Active or past history of central nervous system metastasis from the primary tumor
  • Potentially life-threatening infections
  • Patients have used any investigational drug treatment in the month prior to inclusion.
  • Pregnancy or not exercising appropriate birth control during the course of the study. Breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Please refer to this study by its identifier: NCT00436800

Hong Kong
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Sponsors and Collaborators
Study Director: Iris Chan Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00436800     History of Changes
Other Study ID Numbers: L_9281
Study First Received: February 16, 2007
Last Updated: September 17, 2009

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017