Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLC

NCT02179567 | Terminated Phase 2

• 1 other identifier: CT/10.03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

The investigators propose to study the efficacy and safety of the combination of Docetaxel plus Bevacizumab in a Phase II trial of elderly subjects with non-small cell lung cancer

Conditions

NSCLC

Keywords

Metastatic NSCLC; Elderly; 1st Line; Bevacizumab-based treatment

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Disease evaluation at Week 9

Secondary Outcomes (4)

• Disease control rate

  Disease evaluation at Week 9

• Progression Free Survival

  1 year

• Overall Survival

  1 year

• Safety Profile

  Every three weeks up to 18 weeks

Study Arms (1)

Doc/Bev

EXPERIMENTAL

Docetaxel/Bevacizumab

Drug: Docetaxel; Drug: Bevacizumab

Interventions

Docetaxel DRUG

Docetaxel: 60mg/m2 i.v on day 1. Cycle repeated ever 3 weeks

Doc/Bev

Bevacizumab DRUG

Bevacizumab: 7.5 mg/kg, iv on day 1. Cycle repeated every 3 weeks

Doc/Bev

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years old
• Cytologically or histologically documented NSCLC
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
• World Health Organisation (WHO) performance status 0-2
• Non-frail patients according to Comprehensive Geriatric Assessment
• No prior chemotherapy
• Life expectancy of at least 12 weeks
• Serum bilirubin less than 1.5 times the upper normal limit
• Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
• Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min
• Neutrophil count more than 1.5x 109 /L
• Platelet count more than 100x 109 /L
• Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

You may not qualify if:

• Hemoptysis
• Central nervous system metastases
• Hemorrhagic diathesis or coagulopathy
• Anticoagulation therapy; regular use of aspirin (\>325 mg/d), nonsteroidal anti-inflammatory agents, or other agents known to inhibit platelet function
• Major surgery within 28 days before enrolment
• Clinically significant cardiovascular disease
• Medically uncontrolled hypertension
• Radiological evidence of tumors invading or abutting major blood vessels
• Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
• Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (5)

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Heraklion, Crete, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens Athens, Greece

Athens, Greece

Location

Medical Oncology Unit NIMTS (Veterans Hospital)

Athens, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Bevacizumab

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lambros Vamvakas, MD

  University Hospital of Herklion

  PRINCIPAL INVESTIGATOR

• Athanasios Karambeazis, MD

  Medical Oncology Unit NIMTS (Veterans Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

GR (5)