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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00436800
First received: February 16, 2007
Last updated: September 17, 2009
Last verified: August 2009
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Safety: Clinical and laboratory criteria [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events (SAE) [ Time Frame: Baseline to 30 days post treatment ] [ Designated as safety issue: Yes ]
  • Drop-out rate [ Time Frame: End of study ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436800

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00436800     History of Changes
Other Study ID Numbers: L_9281
Study First Received: February 16, 2007
Last Updated: September 17, 2009
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on October 23, 2014