Clinical trial NCT01534585: Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma
Official title: Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma(NPC)
Icotinib
Intensity Modulation Radiation Therapy(IMRT)
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC
timeFrame: 30 days
measure: Phase II: 2 years locoregional control rate
timeFrame: Two years
Secondary outcomes:
measure: The overall response rate (complete and partial response)
timeFrame: 1 month following treatment and then every 3 months
measure: The acute and late toxicity profile associated with the study regimen
timeFrame: 1 month following treatment and then every 3 months
measure: The duration of control of locoregional disease
timeFrame: 1 month following treatment and then every 3 months
measure: Overall survival, disease-free survival, and distant relapse rates
timeFrame: At time of locoregional disease progression
measure: EGFR status in tissue and blood before treatment
timeFrame: 2 week of pretreatment
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
name: Haihua Yang, MD.
role: STUDY_DIRECTOR
affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
name: Wei Hu, MD.
role: STUDY_CHAIR
affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
name: Wei Wang, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
name: Chao Zhou, MD.
role: PRINCIPAL_INVESTIGATOR
References: