Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
This study has been terminated.
Sponsor:
University of Malaya
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Ho Gwo Fuang, University of Malaya
ClinicalTrials.gov Identifier:
NCT01230476
First received: October 18, 2010
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: Cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma |
Resource links provided by NLM:
Further study details as provided by University of Malaya:
Primary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings
- Progression and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]To assess the PFS and OS at one year
| Enrollment: | 3 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cetuximab and chemotherapy
2 cycles of neoadjuvant cisplatin and 5FU (3 weekly), given with weekly cetuximab, followed by 7 doses of weekly cisplatin and cetuximab concurrent with radiotherapy
|
Drug: Cetuximab
Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed written informed consent
- Inpatients or outpatients, 18-65 years of age
- Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
- Evidence of unidimensional measurable disease as per RECIST criteria
- No systemic metastatic disease (M0)
- ECOG performance status of 0 or 1 at study entry
- Effective contraception
- White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
- Total bilirubin ≤ 1.5x upper reference range
- AST & ALT ≤ 1.5x upper reference range
- Glomerular filtration rate > 60 ml/min
- Serum creatinine ≤ 1.25x upper reference range
Exclusion Criteria:
- Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
- Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
- Known hypersensitivity reaction to any of the components of study treatments
- Pregnancy or lactation period
- Systemic metastatic disease
- Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- Peripheral neuropathy > grade 1
- Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
- Known alcohol or drug abuse
- Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
- Legal incapacity or limited legal capacity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230476
Locations
| Malaysia | |
| University Malaya Medical Centre | |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100 | |
Sponsors and Collaborators
University of Malaya
Merck Serono International SA
Investigators
| Principal Investigator: | Gwo Fuang Ho, FRCR | University Malaya |
More Information
No publications provided
| Responsible Party: | Ho Gwo Fuang, Medical Lecturer, University of Malaya |
| ClinicalTrials.gov Identifier: | NCT01230476 History of Changes |
| Other Study ID Numbers: | EMR 62202-832 |
| Study First Received: | October 18, 2010 |
| Last Updated: | May 29, 2013 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by University of Malaya:
|
Locally advanced nasopharyngeal carcinoma Neoadjuvant chemotherapy Chemoradiation Cetuximab |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013