Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer
- Registration Number
- NCT02980809
- Lead Sponsor
- First Hospitals affiliated to the China PLA General Hospital
- Brief Summary
The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.
- Detailed Description
Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC patients. However, even in sensitive patients, only 20% response rate and a median time to progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2. It has been approved in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- limited or extensive-stage SCLC who had failed to first-line therapy
- ≥18 years old
- Eastern Cooperative Oncology Group performance status ≤2
- at least one measurable lesion as defined by RECIST (version 1.1)
- at least one measurable lung tumor lesion
- WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL
- AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases.
- symptomatic CNS metastases
- concomitant or previous malignancies within the last 5 years
- severe comorbidities; prior topotecan therapy
- hypersensitivity or other contraindication to the study drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apatinib and topotecan Apatinib Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression. Apatinib and topotecan Topotecan Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression. Topotecan Topotecan Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.
- Primary Outcome Measures
Name Time Method Progression-free survival 1 year
- Secondary Outcome Measures
Name Time Method Response rate 1 year Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0 1 year Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0