We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436800
First Posted: February 19, 2007
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436800


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00436800     History of Changes
Other Study ID Numbers: L_9281
First Submitted: February 16, 2007
First Posted: February 19, 2007
Last Update Posted: September 18, 2009
Last Verified: August 2009

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