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

NCT02945852 | Completed Phase 2

• 1 other identifier: zjSAPA001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  3 months

Secondary Outcomes (2)

• Tumor response rate

  3 months

• Treatment-related adverse events

  3 months

Study Arms (1)

refractory SCLC

EXPERIMENTAL

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

Drug: apatinib

Interventions

apatinib DRUG

apatinib 500mg/d until progressive Disease

refractory SCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fan Yun, MD: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 31523058 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: November 15, 2018
• Study Completion: May 26, 2019
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)