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

Nasopharyngeal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436800
• Other study ID #: L_9281
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: September 17, 2009
• Start date: March 2005
• Est. completion date: October 2008

Study information

• Verified date: August 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Drug:
• Gemcitabine
1000mg/m² over 10mg/m²/min
• Oxaliplatin
100 mg/m² over 2 hours.

Locations

Country	Name	City	State
Hong Kong	Sanofi-Aventis Administrative Office	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria		Baseline to end of study	No
Primary	Safety: Clinical and laboratory criteria		Baseline to end of study	Yes
Primary	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	Yes
Primary	Occurrence of serious adverse events (SAE)		Baseline to 30 days post treatment	Yes
Primary	Drop-out rate		End of study	No
Secondary	Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.		Baseline to end of study	No