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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Neoplasms
• Intervention / Treatment: Drug: Gemcitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.	Baseline to end of study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Iris Chan, Sanofi

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: February 16, 2007
• First Submitted That Met QC Criteria: February 16, 2007
• First Posted (Estimate): February 19, 2007

Study Record Updates

• Last Update Posted (Estimate): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Oxaliplatin
• Other Study ID Numbers: L_9281