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

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Apatinib

Topotecan

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apatinib and topotecan

Topotecan

Arm Description

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Response rate

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

Full Information

NCT ID

NCT02980809

First Posted

November 24, 2016

Last Updated

December 1, 2016

Sponsor

First Hospitals affiliated to the China PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02980809

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2017 (undefined)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Hospitals affiliated to the China PLA General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib and topotecan

Arm Type

Experimental

Arm Description

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.

Arm Title

Topotecan

Arm Type

Placebo Comparator

Arm Description

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Type

Drug

Intervention Name(s)

Topotecan

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Response rate

Time Frame

1 year

Title

Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0

Description

Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min-hang Zhou

Phone

86-10-66848733

zhou_minhang@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17135646

Citation

O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia 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. doi: 10.1200/JCO.2006.06.5821.

Results Reference

background

PubMed Identifier

17513814

Citation

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. doi: 10.1200/JCO.2006.08.3998. Erratum In: J Clin Oncol. 2007 Aug 1;25(22):3387.

Results Reference

background

PubMed Identifier

26884585

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. Epub 2016 Feb 16.

Results Reference

background

PubMed Identifier

23813929

Citation

Fruh M, De Ruysscher D, Popat S, Crino 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. Epub 2013 Jun 27. No abstract available.

Results Reference

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

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