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

December 1, 2016 updated by: Min-hang Zhou, First Hospitals affiliated to the China PLA General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Topotecan
Drug: Apatinib
Placebo Comparator: Topotecan
Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.
Drug: Topotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 1 year
1 year
Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0
Time Frame: 1 year
Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospitals affiliated to the China PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gsk-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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