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Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Vinorelbine

Bevacizumab

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Vinorelbine, Bevacizumab, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed, metastatic (stage IV) non small cell lung cancer
One previous platinum based chemotherapy regimen with or without taxanes for metastatic NSCLC
Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
Age ≥ 18 years
Performance status (WHO) 0-2
Life expectancy of at least 12 weeks
Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)
Patients must be able to understand the nature of this study
Written informed consent

Exclusion Criteria:

Second primary malignancy, except for non-melanoma skin cancer. Pregnant or lactating women
Any serious, uncontrolled comorbidity on the investigator's judgment
Uncontrolled infection
Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
Brain metastases, except if radiated and asymptomatic
Radiotherapy within the previous 4 weeks
Previous radiotherapy to the only measurable lesion
Proteinuria ≥ 500 mgr of protein daily
Hemoptysis > 10 cc per event
Clinically significant hematemesis
Centrally located lesion or in contact with major vessels
Pulmonary lesion with cavitation
Documented hemorrhagic diathesis or coagulation disorder
Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
Thrombotic event within the previous 6 months
Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
Concurrent treatment with other anti-cancer drug
Major surgical procedure within the previous 4 weeks
Serum Να+ < 120mg/dL

Sites / Locations

University General Hospital of Alexandroupolis, Dep of Medical Oncology
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
401 Military Hospital of Athens
Air Forces Military Hospital of Athens
University Hospital of Crete, Dep of Medical Oncology
State General Hospital of Larissa, Dep of Medical Oncology
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Vinorelbine metronomic + bevacizumab

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Toxicity profile

Progression free survival

Overall survival

Full Information

NCT ID

NCT00755170

First Posted

September 17, 2008

Last Updated

October 3, 2016

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00755170

Brief Title

Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer

Official Title

A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer

Detailed Description

Intravenous (IV) vinorelbine is a standard chemotherapy option for the treatment of metastatic NSCLC, either alone or in combination with other agents such as CDDP or Carboplatin with overall response rates (ORR) of 15-35% as 1st line treatment and less than 10% as salvage treatment. For the past few years vinorelbine is available for per os (po) administration with acceptable and reliable pharmacokinetic profiles and with a bioavailability of approximately 40% of the IV dose. In randomized phase II studies IV and po vinorelbine have shown comparable response and overall survival rates. The low dose metronomic chemotherapy that is administered in short intervals has been shown in vitro an in vivo to have antiangiogenic effects. Bevacizumab is a well known anti-angiogenic agent. Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. This study will evaluate the combination of metronomic vinorelbine and bevavizumab as 2nd line treatment of NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Vinorelbine, Bevacizumab, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Vinorelbine metronomic + bevacizumab

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Other Intervention Name(s)

Navelbine

Intervention Description

Metronomic vinorelbine (p.o) 30 mg total dose/day, every Monday, Wednesday and Friday of each week, continuously without intervals for the equivalence of 6 cycles maximum

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks for 6 cycles maximum followed by Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression

Primary Outcome Measure Information:

Title

Response rate

Time Frame

Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measure Information:

Title

Toxicity profile

Time Frame

Toxicity assessment on each cycle

Title

Progression free survival

Time Frame

1 year

Title

Overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed, metastatic (stage IV) non small cell lung cancer One previous platinum based chemotherapy regimen with or without taxanes for metastatic NSCLC Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm Age ≥ 18 years Performance status (WHO) 0-2 Life expectancy of at least 12 weeks Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit) Patients must be able to understand the nature of this study Written informed consent Exclusion Criteria: Second primary malignancy, except for non-melanoma skin cancer. Pregnant or lactating women Any serious, uncontrolled comorbidity on the investigator's judgment Uncontrolled infection Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0) Brain metastases, except if radiated and asymptomatic Radiotherapy within the previous 4 weeks Previous radiotherapy to the only measurable lesion Proteinuria ≥ 500 mgr of protein daily Hemoptysis > 10 cc per event Clinically significant hematemesis Centrally located lesion or in contact with major vessels Pulmonary lesion with cavitation Documented hemorrhagic diathesis or coagulation disorder Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension) Thrombotic event within the previous 6 months Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents Concurrent treatment with other anti-cancer drug Major surgical procedure within the previous 4 weeks Serum Να+ < 120mg/dL

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sofia Agelaki, MD

Organizational Affiliation

University Hospital of Crete, Dep of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University General Hospital of Alexandroupolis, Dep of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

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

City

Athens

Country

Greece

Facility Name

401 Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

University Hospital of Crete, Dep of Medical Oncology

City

Heraklion

Country

Greece

Facility Name

State General Hospital of Larissa, Dep of Medical Oncology

City

Larissa,

Country

Greece

Facility Name

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

City

Thessaloniki

Country

Greece

Facility Name

Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

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Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer

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