Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)

Locally Advanced/ Metastatic NSCLC Clinical Trial

— VINORELBINA  

Official title:

Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208854
• Other study ID #: VINORELBINA
• Status: Recruiting
• Start date: April 18, 2018
• Est. completion date: May 18, 2020

Study information

• Verified date: December 2019
• Source: International Group of Endovascular Oncology
• Contact: DAVID ROSSI, MD
• Phone: +390721364093
• Email: david.rossi[@]ospedalimarchenord.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Description:

Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 18, 2020
• Est. primary completion date: April 18, 2020
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of histologically documented NSCLC (adenocarcinoma and squamous carcinoma), stage IIIB (not eligible for surgery or chemo-radiotherapy) and stage IV according to the 8th edition of TNM

• "Wild type" for EGFR, ALK and PDL-1

• Age = 70 years

• PS 0 - 2

• Adequate medullary reserve (neutrophils> 1500; PLT> 100,000 mm3); hepatic / renal function preserved

• Written informed consent

Exclusion Criteria:

• Gastrointestinal disorders that contraindicate the intake of the capsules (type ulcerative colitis or Chron's disease).

• Performance Status ECOG = 3

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced/ Metastatic NSCLC

Intervention

Drug:
• Vinorelbine
Vinorelbine 40 mg (2 cps of 20 mg) three times a week (Monday. Wednesday, Friday), for the first 2 weeks. Starting from the third week, in the absence of any severe toxicity (= 3) and in the opinion of the clinician, the dosage can be increased to 50 mg (1 cps from 30 + 1 cps from 20 mg), three times a week ( Monday, Wednesday, Friday) continuously. The dosage of 40 or 50 mg is continued until progression, patient refusal or unacceptable toxicity (in the clinician's opinion).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	Yes

Sponsors (2)

Lead Sponsor	Collaborator
International Group of Endovascular Oncology	Azienda Sanitaria Ospedaliera

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TUMOR RESPONSE	STABLE DISEASE	6 MONTHS
Primary	number of adverse events	TOLERANCE TO VINORELBINE	6 MONTHS
Secondary	PFS	PROGRESSION FREE SURVIVAL	1 year
Secondary	OS	OVERALLA SURVIVAL	1 YEAR