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Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

Primary Purpose

Extensive-stage Small Cell Lung Cancer, Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib, Etoposide

About this trial

This is an interventional prevention trial for Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
Performance status of 0～2 on the ECOG criteria
Expected survival is above three months
Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5)
Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria:

suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
Bleeding tendency or coagulation disorders.
Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
Urine protein≥++, or urine protein in 24 hours≥2.0g.
severe uncured wounds, ulcers or fracture.
Pregnant or breast-feeding.
Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
The researcher believe that the Patient is not suitable to participate in the study.

Sites / Locations

Sicchuan cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib, Etoposide

Arm Description

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Outcomes

Primary Outcome Measures

Progression-free survival

The first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Overall survival

the first day of treatment to death or last survival confirm date

Duration of Response

Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse

Tumor response rate

The ratio between the number of responders and number of patients assessable for tumor response.

Quality of Life (QoL) questionnaire

in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.

Full Information

NCT ID

NCT03135977

First Posted

April 27, 2017

Last Updated

December 5, 2017

Sponsor

Sichuan Cancer Hospital and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT03135977

Brief Title

Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

Official Title

A Clincal Trial of Apatinib Mesylate and Etoposide(VP-16) as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.

6. Conditions and Keywords

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

Extensive-stage Small Cell Lung Cancer, Lung Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib, Etoposide

Arm Type

Experimental

Arm Description

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Intervention Type

Drug

Intervention Name(s)

Apatinib, Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Primary Outcome Measure Information:

Title

Progression-free survival

Description

The first day of treatment to the date that disease progression is reported

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

the first day of treatment to death or last survival confirm date

Time Frame

up to 24 months

Title

Duration of Response

Description

Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse

Time Frame

up to 24 months

Title

Tumor response rate

Description

The ratio between the number of responders and number of patients assessable for tumor response.

Time Frame

Time Frame: 3 month

Title

Quality of Life (QoL) questionnaire

Description

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy Performance status of 0～2 on the ECOG criteria Expected survival is above three months Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5) Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up. Exclusion Criteria: suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor). Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction). Bleeding tendency or coagulation disorders. Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg). Urine protein≥++, or urine protein in 24 hours≥2.0g. severe uncured wounds, ulcers or fracture. Pregnant or breast-feeding. Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents). The researcher believe that the Patient is not suitable to participate in the study.

Central Contact Person:

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

Xionghong Cai, Doctor

Phone

8618036672884

xionghong_cai@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xionghong Cai, Doctor

Organizational Affiliation

Sichuan Cancer Hospital and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sicchuan cancer hospital

City

Chendu

State/Province

Sichuan

ZIP/Postal Code

610000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xiaohong Cai, Doctor

Phone

8618036672884

xionghong_cai@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

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