Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma (FMTN-I-LNPC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
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
  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
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: 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

ClinicalTrials.gov processed this record on September 18, 2014