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Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

apatinib;etoposide and cisplatin

placebo;etoposide and cisplatin

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring small cell lung cancer; apatinib; etoposide; cisplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage.
No prior cisplatin-based chemotherapy or radiotherapy.
Males or females between 18 Years to 75 Years.
Performance status of 0～2 on the ECOG criteria.
Expected survival is above three months.
At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).
Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).
Patient can take oral medicine.
Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria:

History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
with brain metastases.
The patients had accepted allogeneic organ transplantation.
Bleeding tendency or coagulation disorders.
patients who need renal dialysis.
suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.
Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.
severe uncured wounds, ulcers or fracture.
uncured dehydration.
Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
Patients are allergic to drugs used in research.
Factors influencing the safety and compliance of patients.
Inability to comply with protocol or study procedures.
Pregnant or breast-feeding.
The researcher believe that the Patient is not suitable to participate in the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD).

Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until 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.

Tumor response rate

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

Treatment-related adverse events

Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.

Performance Status

Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).

Full Information

NCT ID

NCT02875457

First Posted

June 11, 2016

Last Updated

August 23, 2016

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02875457

Brief Title

Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin

Official Title

A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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. Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib as the maintenance therapy for extensive stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.

6. Conditions and Keywords

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

Small Cell Lung Cancer

Keywords

small cell lung cancer; apatinib; etoposide; cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Placebo Comparator

Arm Description

Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD.

Intervention Type

Drug

Intervention Name(s)

apatinib;etoposide and cisplatin

Intervention Type

Drug

Intervention Name(s)

placebo;etoposide and cisplatin

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

5 years

Title

Tumor response rate

Description

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

Time Frame

3 months

Title

Treatment-related adverse events

Description

Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.

Time Frame

the first date of treatment to 30 days after the last dose of study drug,assessed up to 6 months

Title

Performance Status

Description

Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).

Time Frame

the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage. No prior cisplatin-based chemotherapy or radiotherapy. Males or females between 18 Years to 75 Years. Performance status of 0～2 on the ECOG criteria. Expected survival is above three months. At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm). Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5). Patient can take oral medicine. Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up. Exclusion Criteria: History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin). Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II). Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents). with brain metastases. The patients had accepted allogeneic organ transplantation. Bleeding tendency or coagulation disorders. patients who need renal dialysis. suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor). uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg). thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months). pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs. Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs. severe uncured wounds, ulcers or fracture. uncured dehydration. Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect. Patients are allergic to drugs used in research. Factors influencing the safety and compliance of patients. Inability to comply with protocol or study procedures. Pregnant or breast-feeding. 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

Wang Dong, PH.D.

Phone

86-23-68757151

dongwang64@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Dong, PH.D.

Organizational Affiliation

Daping Hospital, Third Military Medical University, Chongqing,China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin

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