NCT01616849
Completed
Phase 2
Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma
Sun Yat-sen University1 site in 1 country39 target enrollmentMay 2012
ConditionsStage IV Nasopharyngeal Carcinoma
Interventionscisplatin and 5-Fu combined with nimotuzumab
Overview
- Phase
- Phase 2
- Intervention
- cisplatin and 5-Fu combined with nimotuzumab
- Conditions
- Stage IV Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Objective response rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
Investigators
Zhao Chong
MD
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Histologic diagnosis of nasopharyngeal carcinoma
- •Distance metastasis at least 6 months after radical treatment
- •Not suitable for local treatment, e.g. surgery, TACE
- •At least one measurable lesion
- •Estimate survival \>3months
- •Range from 18～70 years old
- •WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- •ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN
- •0Serum creatinine \< 1.5×ULN
Exclusion Criteria
- •Central nervous system metastases
- •Suitable for local treatment
- •Second malignancy within 5 years
- •Precious therapy with an investigational agent
- •Uncontrolled seizure disorder or other serious neurologic disease
- •≥ Grade Ш allergic reaction to any drug including in this study
- •Clinically significant cardiac or respiratory disease
- •Creatinine clearance \< 30ml/min
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
Arms & Interventions
PF+ Nimotuzumab
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
Intervention: cisplatin and 5-Fu combined with nimotuzumab
Outcomes
Primary Outcomes
Objective response rate
Time Frame: study period of 19 Months
To be determined by measurement of target lesions according to RECIST criteria
Progression free survival
Time Frame: 19 Months
Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
Secondary Outcomes
- Overall survival(19 Months)
- Quality of life(8 Months)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular CarcinomaHepatocellular CarcinomaNCT06558227Suzhou Zelgen Biopharmaceuticals Co.,Ltd90
Active, not recruiting
Phase 2
ObinutuzuMab AtezOlizumab and VenetocLax in RichTer transfOrmationCLL TransformationNCT04082897Niguarda Hospital28
Unknown
Phase 2
Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer PatientsTriple Negative Breast CancerNCT04502680The First Affiliated Hospital with Nanjing Medical University100
Recruiting
Phase 2
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II TrialMarginal Zone Lymphoma(MZL)NCT06700798Fei Li90
Active, not recruiting
Phase 2
Clinical Study With Ibrutinib and Venetoclax for Patients With Relapsed/Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT04754035Paolo Ghia31