Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma
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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 |
- 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 ]
- 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) |
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with histological proof of squamous carcinoma of the nasopharynx.
- Patients must have ECOG Performance Status of 0-1.
- 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.
- Patients must sign a study specific informed consent form prior to study entry.
Exclusion Criteria:
- Evidence of metastases by clinical or radiographic examinations.
- History of malignancy other than non-melanoma skin cancer.
- 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.
- Patients with uncontrolled intercurrent disease.
- Patients with currently active malignancy.
- 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| Contact: Haihua Yang, MD. | +86-13819639006 | yhh93181@hotmail.com |
| Contact: Wei Hu, MD. | +86-13606657129 | huw@enzemed.com |
| 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 | |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Carcinoma Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
Cisplatin Paclitaxel Mitogens Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Mitosis Modulators Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013