Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00436800
First received: February 16, 2007
Last updated: September 17, 2009
Last verified: August 2009
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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 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:
|
Neoplasms Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Gemcitabine |
Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013