Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00363831
First received: August 11, 2006
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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.

Condition Intervention Phase
Nasopharyngeal Neoplasms
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: A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Overall response rate (based on RECIST criteria) [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Overall survival time [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: July 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxaliplatin
Drug: Oxaliplatin
130mg/m² infusion day 1, repeat every 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363831

Contacts
Contact: Public Registry GMA PublicRegistryGMA@sanofi-aventis.com

Locations
Hong Kong
Sanofi-aventis Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Study Director: Iris Chan Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00363831     History of Changes
Other Study ID Numbers: L_9863
Study First Received: August 11, 2006
Last Updated: July 27, 2010
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Capecitabine
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014