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

Primary Purpose

Nasopharyngeal Neoplasms

Status

Completed

Phase

Phase 2

Locations

Hong Kong

Study Type

Interventional

Intervention

Gemcitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles.

Outcomes

Primary Outcome Measures

Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria

Safety: Clinical and laboratory criteria

The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0

Occurrence of serious adverse events (SAE)

Drop-out rate

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00436800

First Posted

February 16, 2007

Last Updated

September 17, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00436800

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

1000mg/m² over 10mg/m²/min

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

100 mg/m² over 2 hours.

Primary Outcome Measure Information:

Title

Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria

Time Frame

Baseline to end of study

Title

Safety: Clinical and laboratory criteria

Time Frame

Baseline to end of study

Title

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

Title

Occurrence of serious adverse events (SAE)

Time Frame

Baseline to 30 days post treatment

Title

Drop-out rate

Time Frame

End of study

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline to end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iris Chan

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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

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