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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer; Extensive-stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Apatinib, Etoposide

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610000
      • Recruiting
      • Sicchuan cancer hospital
      • Contact: xiaohong Cai, Doctor; Phone Number: 8618036672884; Email: xionghong_cai@hotmail.com

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Apatinib, Etoposide; 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) .	Drug: Apatinib, Etoposide; 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) .; Other Names: VP-16

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The first day of treatment to the date that disease progression is reported	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	the first day of treatment to death or last survival confirm date	up to 24 months
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	up to 24 months
Tumor response rate	The ratio between the number of responders and number of patients assessable for tumor response.	Time Frame: 3 month
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.	up to 24 months

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Investigators: Principal Investigator: Xionghong Cai, Doctor, Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (ACTUAL): May 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Etoposide; Apatinib
• Other Study ID Numbers: Ahead-SL-20170220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No