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

NCT02875457 | Unknown Phase 3 DMC

• 1 other identifier: AEP-ES-SCLC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; apatinib; etoposide; cisplatin

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  6 months

Secondary Outcomes (4)

• Overall survival

  5 years

• Tumor response rate

  3 months

• Treatment-related adverse events

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

• Performance Status

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

Study Arms (2)

Arm A

EXPERIMENTAL

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).

Drug: apatinib;etoposide and cisplatin

Arm B

PLACEBO COMPARATOR

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.

Drug: placebo;etoposide and cisplatin

Interventions

apatinib;etoposide and cisplatin DRUG

Arm A

placebo;etoposide and cisplatin DRUG

Arm B

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.
• 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.

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).
• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wang Dong, PH.D.

  Daping Hospital, Third Military Medical University, Chongqing,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Dong, PH.D.

CONTACT

86-23-68757151; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 11, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2023
• Last Updated: August 24, 2016

Record last verified: 2016-08