Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02980809
• Other study ID #: gsk-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 24, 2016
• Last updated: December 1, 2016
• Start date: March 2017
• Est. completion date: March 2020

Study information

• Verified date: November 2016
• Source: First Hospitals affiliated to the China PLA General Hospital
• Contact: Min-hang Zhou
• Phone: 86-10-66848733
• Email: zhou_minhang[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Apatinib

• Topotecan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospitals affiliated to the China PLA General Hospital

References & Publications (4)

Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. Erratum in: J Clin Oncol. 2007 Aug 1;25(22):3387.. — View Citation

Früh M, De Ruysscher D, Popat S, Crinò L, Peters S, Felip E; ESMO Guidelines Working Group.. Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi99-105. doi: 10.1093/annonc/mdt178. — View Citation

Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. — View Citation

O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		1 year	No
Secondary	Response rate		1 year	No
Secondary	Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0	Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0	1 year	Yes