- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363831
Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma
July 27, 2010 updated by: The University of Hong Kong
A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)
Primary:
- To evaluate the efficacy of capecitabine in combination with oxaliplatin (XELOX) in terms of overall response rate (based on RECIST criteria) in patients with metastatic NPC without prior chemotherapy for relapse.
Secondary:
- To evaluate the efficacy profile of oxaliplatin (XELOX) in patients with metastatic NPC in terms of time to progression of disease, survival time, duration of response and complete response rate.
- To study the safety and tolerability of the regimen in patients with metastatic NPC.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Public Registry GMA
- Email: PublicRegistryGMA@sanofi-aventis.com
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed poorly differentiated or undifferentiated nasopharyngeal carcinoma (WHO type II and III) with distant metastasis (ie. other than loco-regional disease). Patients with stage IVc disease, ie. distant metastases on presentation are also eligible.
- Have at least one measurable lesion according to RECIST which has not been irradiated.
- WBC count ≥ 3 x 10^9 /L with neutrophils ≥ 1.5 x 10^9 /L, platelet count ≥ 100 x 10^9 /L and Hb ≥ 9g/dL.
- Serum creatinine ≤ 1.25 ULN
- Be ambulatory and have a Karnofsky Performance Status of ≥ 70% at study entry.
- Recover from prior radiotherapy prior to study entry
- Effective contraception for both male and female if the risk of conception exists.
- Able to swallow and retain oral medication.
Exclusion Criteria:
- Previous cytotoxic chemotherapy for recurrent or metastatic NPC.
- Previous exposure to oxaliplatin and/or capecitabine.
- Pregnant or lactating women. Women of childbearing potential with either positive or no pregnancy test at baseline. Women of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
- Sexually active males unwilling to practice contraception during the study.
- Clinically significant cardiac disease (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Patients with a history of central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- Abnormal blood counts, AST, ALT, bilirubin and/or serum creatinine beyond the limits specified in the inclusion criteria.
- Radiotherapy within 4 weeks of treatment start or prior radiotherapy to the indicator lesion(s) being measured in the study (newly arising marker lesions in previously irradiated areas are acceptable).
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Participation in any investigational drug study within 4 weeks preceding the start of treatment.
- Symptomatic peripheral neuropathy NCI-CTCAE grade ≥ 2.
- Known allergic/hypersensitivity reaction to any of the components of study treatments.
- Serious uncontrolled intercurrent infections.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Oxaliplatin
|
130mg/m² infusion day 1, repeat every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate (based on RECIST criteria)
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Time to progression
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Overall survival time
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Iris Chan, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 11, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
July 28, 2010
Last Update Submitted That Met QC Criteria
July 27, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Antineoplastic Agents
- Oxaliplatin
Other Study ID Numbers
- L_9863
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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