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

NCT00436800 | Completed Phase 2

• 1 other identifier: L_9281
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.

  Baseline to end of study

Study Arms (1)

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; Drug: Oxaliplatin

Interventions

Gemcitabine DRUG

1000mg/m² over 10mg/m²/min

1

Oxaliplatin DRUG

100 mg/m² over 2 hours.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Iris Chan

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: March 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 18, 2009

Record last verified: 2009-08

Locations

HK (1)