NCT00747799CompletedPhase 2
Phase II Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Are Failure of Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Sun Yat-sen University1 site in 1 country54 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Objective response rate (CR+PR)
Study Overview
Brief Summary
This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •ECOG Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks
- •Pathologically confirmed nasopharyngeal carcinoma
- •Experience of treatment failure with radiotherapy for recurrent or metastatic NPC
- •More than 3 weeks must have elapsed since previous radiotherapy
- •Biomarkers measuring including pERK, EGFR of original diagnostic paraffin-embedded tumor samples; VEGF of pre-dose and post-dose plasma samples.
- •Subjects with at least one (for RECIST) measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable)
- •Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) > 1,500/mm3
- •Platelet count > 100,000/μl
- •Total bilirubin < 1.5 times the upper limit of normal
- •ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer), Alkaline phosphatase < 4 x ULN ,PT-INR/PTT < 1.5 x upper limit of normal, Serum creatinine < 1.5 x upper limit of normal
- •Signed and dated informed consent before the start of specific protocol procedures
Exclusion Criteria
- •History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •History of HIV infection
- •Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- •History of organ allograft the organ allograft may be allowed as protocol specific.
- •Patients with evidence or history of bleeding diatheses
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- •Patients unable to swallow oral medications
- •Prior use of farnesyl transferase, Raf kinase, or MEK inhibitors
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Prior exposure to the study drug
Arms & Interventions
1
Experimental
Sorafenib with Cisplatin and 5-fluorouracil as first-line treatment of recurrence after radiotherapy patients who failed with radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC)
Intervention: Sorafenib plus Cisplatin and 5-fluorouracil (Drug)
Outcomes
Primary Outcomes
Objective response rate (CR+PR)
Time Frame: January 2009 to May 2011
In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.
Secondary Outcomes
- Disease control rate(January 2009 to May 2011)
Investigators
Li Zhang
Profressor
Sun Yat-sen University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue SarcomaPleomorphic RhabdomyosarcomaStage IIB Adult Soft Tissue Sarcoma AJCC v7Stage III Adult Soft Tissue Sarcoma AJCC v7Stage IV Adult Soft Tissue Sarcoma AJCC v7NCT02050919OHSU Knight Cancer Institute20
Unknown
Not Applicable
Combined Radiotherapy and Sorafenib in Patients With HepatomaHepatocellular CarcinomaNCT01319942China Medical University Hospital45
Completed
Phase 2
Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma MultiformeGlioblastoma MultiformeNCT00544817SCRI Development Innovations, LLC47
Withdrawn
Phase 2
Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With IrinotecanPediatric Solid TumorsNCT02747537Washington University School of Medicine
Completed
Phase 1
Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT00712790Singapore Clinical Research Institute35