Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00436800

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	40
Study Start Date:	March 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Locations

Hong Kong
Sanofi-aventis
Hong Kong, Hong Kong

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Iris Chan

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_9281
Study First Received:	February 16, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00436800 History of Changes
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Antimetabolites
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Nasopharyngeal Carcinoma
Immunologic Factors
Pharyngeal Neoplasms
Immunosuppressive Agents
Antiviral Agents
Pharyngeal Diseases

Nasopharyngeal Neoplasms
Recurrence
Carcinoma
Oxaliplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Stomatognathic Diseases
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Otorhinolaryngologic Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Nasopharyngeal Neoplasms
Oxaliplatin
Neoplasms by Site
Therapeutic Uses

Nasopharyngeal Diseases
Gemcitabine
Otorhinolaryngologic Diseases
Enzyme Inhibitors
Pharyngeal Diseases
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 02, 2009