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Apatinib for Extensive Stage Small Cell Lung Cancer After Second/Third Line Chemotherapy.

Primary Purpose

Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

apatinib

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

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.

Previous treatments including first-line therapy with EP or CE and second-line therapy with topotecan; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Males or females between 18 Years to 75 Years. 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).

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. 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

Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

refractory SCLC

Arm Description

Patients receive apatinib 500mg/d 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

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.

Full Information

NCT ID

NCT02945852

First Posted

October 25, 2016

Last Updated

July 16, 2022

Sponsor

Fan Yun, MD

1. Study Identification

Unique Protocol Identification Number

NCT02945852

Brief Title

Apatinib for Extensive Stage Small Cell Lung Cancer After Second/Third Line Chemotherapy.

Official Title

Phase II Study of Apatinib as Third- or Further-line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

November 15, 2018 (Actual)

Study Completion Date

May 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Fan Yun, MD

4. Oversight

5. Study Description

Brief Summary

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. 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. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in refractory or recurrent ED-SCLC patients in our center.

Detailed Description

Small cell lung cancer (SCLC) is a highly aggressive disease characterized by its rapid doubling time, high growth fraction, early development of disseminated disease, and dramatic response to first-line chemotherapy and radiation. Small cell lung cancer accounts for approximately 20%-25% lung cancer patients. SCLC patients are categorized as limited disease, defined as disease that is confined to the ipsilateral hemithorax that can be encompassed within a tolerable radiation port, or extensive disease (ED), defined as the presence of overt metastatic disease determined by imaging or physical examination. Two third of patients are diagnosed with ED at presentation. Despite the development of novel cytotoxic drugs, the therapeutic approach to SCLC has been stagnant for more than twenty years. Standard treatment for ED-SCLC remains EP or CE, a regimen that yield a median survival of approximately 9 months and a 5-year survival of less than 1%.In some guidelines for SCLC, topotecan is recommended as the standard second-line treatment in patients who relapse less than 3 months. As for patients who relapse more than six months after the end of initial treatment, EP or CE regimen is recommended to be used again.There is no standard treatment recommendation for this group of patients who failed to second-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.And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in refractory or recurrent ED-SCLC patients.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

refractory SCLC

Arm Type

Experimental

Arm Description

Patients receive apatinib 500mg/d until progressive Disease(PD).

Intervention Type

Drug

Intervention Name(s)

apatinib

Intervention Description

apatinib 500mg/d until progressive Disease

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

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

3 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. Previous treatments including first-line therapy with EP or CE and second-line therapy with topotecan; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Males or females between 18 Years to 75 Years. 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). 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. 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.

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31523058

Citation

Xu Y, Huang Z, Lu H, Yu X, Li Y, Li W, Chen J, Chen M, Gong L, Chen K, Qin J, Xu X, Jin Y, Zhao J, Shi X, Han N, Xie F, Zhang P, Xu W, Fan Y. Apatinib in patients with extensive-stage small-cell lung cancer after second-line or third-line chemotherapy: a phase II, single-arm, multicentre, prospective study. Br J Cancer. 2019 Oct;121(8):640-646. doi: 10.1038/s41416-019-0583-6. Epub 2019 Sep 16.

Results Reference

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Apatinib for Extensive Stage Small Cell Lung Cancer After Second/Third Line Chemotherapy.

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