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Trial record 7 of 396 for:    nasopharyngeal cancer | "Nasopharyngeal Carcinoma"

Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Taizhou Hospital
Sponsor:
Information provided by (Responsible Party):
Haihua Yang, Taizhou Hospital
ClinicalTrials.gov Identifier:
NCT01534585
First received: February 13, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer. Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC. However, concurrent chemoradiotherapy increased significantly local and systemic toxic effects, which may preclude many patients from proceeding with combined therapy. The epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter survival following chemoradiotherapy in locoregionally advanced NPC. And some basic researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line. Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in patients with NPC. This regimen is of great interest and it has potential to alleviate the adverse effects, improve patient compliance and better therapeutic ratio.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Icotinib
Radiation: intensity-modulated radiotherapy
Drug: Paclitaxel and Cisplatin
Other: Quality of life
Genetic: Epidermal growth factor receptor status
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer

Resource links provided by NLM:


Further study details as provided by Taizhou Hospital:

Primary Outcome Measures:
  • Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Phase II: 2 years locoregional control rate [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The overall response rate (complete and partial response) [ Time Frame: 1 month following treatment and then every 3 months ] [ Designated as safety issue: No ]
  • The acute and late toxicity profile associated with the study regimen [ Time Frame: 1 month following treatment and then every 3 months ] [ Designated as safety issue: Yes ]
  • The duration of control of locoregional disease [ Time Frame: 1 month following treatment and then every 3 months ] [ Designated as safety issue: No ]
  • Overall survival, disease-free survival, and distant relapse rates [ Time Frame: At time of locoregional disease progression ] [ Designated as safety issue: No ]
  • EGFR status in tissue and blood before treatment [ Time Frame: 2 week of pretreatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Icotinib

    Oral Icotinib begins on day 1 and continues until completion of radiotherapy. Phase I:The initial plan is to accrue 6 patients to each dose level (125mg, qd and bid and tid) in each cohort. If one or none of six patients have dose limiting toxicity (DLT), then escalation will proceed. If DLT occurs in two or more patients at a dose level, then escalation will be stopped. The dose level below that at which two of six patients experience a DLT is defined as the maximum-tolerated dose. A minimum of 4 weeks of observation is required after completion of radiation within each Icotinib dose level before accrual to the next level.

    Phase II:According to the maximum tolerated dose, 50 patients will been recruited.

    Other Name: Conmana
    Radiation: intensity-modulated radiotherapy
    The nasopharyngeal regions and upper neck with IMRT plans will be generated and approved for each patient, whereas the low-neck and supraclavicular regions will be used with a conventional anterior field. A total of 70-76Gy at 2.12-2.3Gy/fraction/d will be given to the GTVnx, the GTVnd will receive 66-70Gy at 2.0-2.12Gy/fraction/d, the CTV1 will receive 60-66Gy at 1.8-2.0Gy/fraction/d, and the CTV2 received 56-60Gy at 1.7-1.8Gy/fraction/d with IMRT. The low-neck and supraclavicular regions will receive 50-60Gy at 2.0Gy/fraction/d with conventional radiotherapy. Target prescription dose and critical structures limit dose are planned according to the RTOG0225 trial.
    Other Name: IMRT
    Drug: Paclitaxel and Cisplatin
    AC that consisted of two cycles of paclitaxel 135 mg/m2 on day 1 plus cisplatin 30 mg/m2 on days 1-3 will start 4 weeks after the end of CRT.
    Other: Quality of life
    The EORTC QLQ-C30 and H&N35 of the Chinese version, which is obtained from the Quality of Life Unit, EORTC Data Center in Brussels, Belgium, is available and easily completed by our patients are chosen for this study. Patients will complete the questionnaire before treatment and after treatment and one month after treatment and three months after treatment and one year after treatment.
    Other Name: QoL
    Genetic: Epidermal growth factor receptor status
    EGFR expression and mutation before treatment.
    Other Name: EGFR
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histological proof of squamous carcinoma of the nasopharynx.
  2. Patients must have ECOG Performance Status of 0-1.
  3. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100,000 cells/mm3; adequate hepatic function with bilirubin </= 1.5mg/dl, AST and ALT </= 2x the upper limit of normal; serum creatinine </= 1.5mg/dl, creatinine clearance >/= 50 ml/min and INR 0.8 - 1.2.
  4. Patients must sign a study specific informed consent form prior to study entry.

Exclusion Criteria:

  1. Evidence of metastases by clinical or radiographic examinations.
  2. History of malignancy other than non-melanoma skin cancer.
  3. Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
  4. Patients with uncontrolled intercurrent disease.
  5. Patients with currently active malignancy.
  6. Pregnant or lactating women Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.
  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: NCT01534585

Contacts
Contact: Haihua Yang, MD. +86-13819639006 yhh93181@hotmail.com
Contact: Wei Hu, MD. +86-13606657129 huw@enzemed.com

Locations
China, Zhejiang
Taizhou Hospital, Wenzhou Medical College Recruiting
Taizhou, Zhejiang, China, 317000
Contact: Haihua Yang, MD.    +86-85120120 ext 3192    yhh93181@hotmail.com   
Contact: Wei Hu, MD.    +86-85120120 ext 3192    huw@enzemed.com   
Sponsors and Collaborators
Taizhou Hospital
Investigators
Study Director: Haihua Yang, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Study Chair: Wei Hu, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Principal Investigator: Wei Wang, BS Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Principal Investigator: Chao Zhou, MD. Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
  More Information

No publications provided

Responsible Party: Haihua Yang, Director of Radiotherapy Dept, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT01534585     History of Changes
Other Study ID Numbers: YHH-201201
Study First Received: February 13, 2012
Last Updated: February 16, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Taizhou Hospital:
nasopharyngeal carcinoma(NPC)
Icotinib
Intensity Modulation Radiation Therapy(IMRT)

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Carcinoma
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Cisplatin
Mitogens
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014