Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT00363831

Last Updated: 2010-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31

Brief Summary

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.

Conditions

Nasopharyngeal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Oxaliplatin

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

130mg/m² infusion day 1, repeat every 21 days

Interventions

Oxaliplatin

130mg/m² infusion day 1, repeat every 21 days

Intervention Type: DRUG

Eligibility 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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Iris Chan

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Public Registry GMA

Role: CONTACT

PublicRegistryGMA@sanofi-aventis.com

Other Identifiers

L_9863

Identifier Type: -

Identifier Source: org_study_id