NCT00700440

Brief Summary

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 26, 2010

Completed
Last Updated

March 26, 2010

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

June 17, 2008

Results QC Date

January 11, 2010

Last Update Submit

March 9, 2010

Conditions

Nasopharyngeal Carcinoma

Keywords

RadiotherapychemotherapyDrug Targetingloco-regionally advanced nasopharyngeal carcinomaSafety.efficacy

Outcome Measures

Primary Outcomes (1)

  • 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy

    The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.

    3 months

Secondary Outcomes (1)

  • 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival

    5 year

Study Arms (1)

Cetuximab

EXPERIMENTAL

400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy

Drug: C225 (cetuximab)

Interventions

C225 (cetuximab)DRUG

one week before and then weekly during radiotherapy

Also known as: Erbitux
Cetuximab

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent form signed prior to study entry
  • Age between 18-69 years old
  • Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
  • Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
  • Primary tumor measurable
  • KPS score ≥80
  • Expected life span ≥6 months
  • Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
  • Adequate liver function: ALAT/ASAT\<1.5 × upper limit of normal (ULN), bilirubin \<1.5×ULN
  • Adequate renal function: Creatinine Clearance \< 1.5×ULN

You may not qualify if:

  • Evidence of distant metastatic disease
  • Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
  • Previous radiotherapy for the primary tumor or lymph nodes
  • Previous exposure to epidermal growth factor-targeted therapy
  • Prior chemotherapy or immunotherapy for the primary tumor
  • Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
  • Any investigational agent prior to the 1st study medication
  • Peripheral neuropathy \> grade 1
  • Known grade 3 or 4 allergic reaction to any of the study treatment
  • History of severe pulmonary or cardiac disease
  • Creatinine Clearance \< 30ml/min
  • Know drug abuse / alcohol abuse
  • Legal incapacity or limited legal capacity
  • Active systemic infection
  • Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (5)

  • Sung FL, Poon TC, Hui EP, Ma BB, Liong E, To KF, Huang DP, Chan AT. Antitumor effect and enhancement of cytotoxic drug activity by cetuximab in nasopharyngeal carcinoma cells. In Vivo. 2005 Jan-Feb;19(1):237-45.

    PMID: 15796181BACKGROUND

  • Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

    PMID: 16467544BACKGROUND

  • Kiss R, Salmon I, Pauwels O, Gras S, Danguy A, Etievant C, Pasteels JL, Martinez J. In vitro influence of gastrin, oestradiol and gonadotropin-releasing hormone on HCT-15 and LoVo human colorectal neoplastic cell proliferation. Eur J Cancer. 1991;27(10):1268-74. doi: 10.1016/0277-5379(91)90095-u.

    PMID: 1835597BACKGROUND

  • Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646.

    PMID: 16314626BACKGROUND

  • Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. doi: 10.1200/JCO.2006.08.8005.

    PMID: 17538164BACKGROUND

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Lu Tai-xiang
Organization
Cancer Center, Sun Yat-sen University
lutx@mail.sysu.edu.cn
86-20-87343372

Study Officials

  • Tai-xiang Lu, M.D.

    Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Tong-yu Lin, M.D., PhD

    Departments of Chemotherapy, Cancer Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 26, 2010

Results First Posted

March 26, 2010

Record last verified: 2009-02

Locations

CN(1)