MedDataX Logo

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

NCT ID: NCT02980809

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apatinib and topotecan

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

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Topotecan

Intervention Type DRUG

Topotecan

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

Group Type PLACEBO_COMPARATOR

Topotecan

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apatinib

Intervention Type DRUG

Topotecan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Min-hang Zhou

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Min-hang Zhou

Role: CONTACT

Phone: 86-10-66848733

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17135646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17513814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26884585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23813929 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

gsk-001

Identifier Type: -

Identifier Source: org_study_id