Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma (FMTN-I-LNPC)
This study is currently recruiting participants.
Verified November 2011 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01462474
First received: October 27, 2011
Last updated: November 14, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is manageable.
PURPOSE: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced Nasopharyngeal Carcinoma |
Drug: Famitinib Drug: Cisplatin Radiation: radiation(IMRT) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:
Primary Outcome Measures:
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib
Secondary Outcome Measures:
- ORR (Objective Response Rate) [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
- OS(Overall Survival) [ Time Frame: 2 years and 3 years ] [ Designated as safety issue: No ]
- DFMR(Distant Free Metastases Rate) [ Time Frame: 2 years and 3 years ] [ Designated as safety issue: No ]
- DFSR(Disease Free Survival Rate) [ Time Frame: 2 years and 3 years ] [ Designated as safety issue: No ]
- LFRSR(Local Free Recurrence Survival Rate) [ Time Frame: 2 years and 3 years ] [ Designated as safety issue: No ]
- Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- To identify the tumor's molecular profiles in patients with NPCs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To measure the changes of serum c-Kit,VEGF,Filt,KDR,and PDGFR [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 21 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Drug: Famitinib |
Drug: Famitinib
Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.
Drug: Cisplatin
100 mg/m2, D1, D22, and D43(q3w)
Radiation: radiation(IMRT)
IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, WHO II or III
- Newly diagnosed T3-4N1(exception metastatic uni or bil retropharyngeal lymph nodes N1) or any TN2-3(7th UICC/AJCC) locally advanced nasopharyngeal carcinoma
- 18-65 years of age
- ECOG performance status of 0 or 1
- Life expectancy of more than 6 months
- At least one measurable lesion :MRI scan larger than 10 mm in diameter, malignant lymph nodes larger than 10 mm in short axis
- Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion Criteria:
- Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration
- Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI Screening
- Imageology shows that tumor lesion less than 5 mm to great vessels(internal carotid and jugular vein)
- Hemoglobin < 90g/L, platelets < 100×10^9/L, neutrophils < 2×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), ALT\AST ≥ 1.5x ULN), serum creatine > 1x ULN, creatinine clearance rate < 60ml/min, Cholesterol > 7.75 mmol/L and triglyceride > 3 mmol/L, LVEF: < LLN
- Hypertensive( more than 140/90 mmHg ), more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥470 ms), or cardiac insufficiency
- URT: urine protein ≥ ++ and > 1.0 g of 24 h
- Long-term untreated wounds or fractures
- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- Before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
- Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
- Abuse of Psychiatric drugs or dysphrenia
- Subject of Viral hepatitis type B or type C
- Subject of immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
- With drug CYP3A4 inhibitor, inducer, or substrate
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462474
Locations
| China, Guangdong | |
| Department of Medical Oncology, Cancer Center, Sun Yet-sen University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Jun Ma, MD 8602087343469 majun@sysucc.org.cn | |
| Contact: Haiqiang Mai, MD 8602087343469 maihq@sysucc.org.cn | |
| Principal Investigator: Jun Ma, MD | |
| Principal Investigator: Haiqiang Mai, MD | |
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
More Information
No publications provided
| Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01462474 History of Changes |
| Other Study ID Numbers: | FMTN-I-LNPC |
| Study First Received: | October 27, 2011 |
| Last Updated: | November 14, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
|
Concurrent Chemoradiotherapy |
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 Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013