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Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Vinorelbine

Cisplatin

Bevacizumab

Docetaxel

Gemcitabine

Bevacizumab

Docetaxel

Cisplatin

Bevacizumab

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Cisplatin, VInorelbine, Docetaxel, Gemcitabine, Bevacizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC
Performance status (WHO) 0-1
Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min)
No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed
--Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields
Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
Patient able to take oral medication
Absence of active CNS disease
Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available
Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

Pregnant or lactating women
Women of child-bearing age unable or unwilling to take effective contraceptive measures
Active CNS disease, brain metastases, or leptomeningeal involvement
Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0)
Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months
Active infection, requiring IV antibiotic treatment, within the previous 2 weeks
Long-term oxygen therapy
Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
Radiotherapy within the previous 4 weeks
Previous radiotherapy to the only measurable lesion
Concurrent treatment with other anti-cancer drug
Uncontrolled hypercalcemia
Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or equivalent) for more than one month

Sites / Locations

University General Hospital of Alexandroupolis, Dep of Medical Oncology
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
401 Military Hospital, Medical Oncology Unit
Air Forces Military Hospital, Dep of Medical Oncology
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
"Theagenion" Anticancer Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

NC/Avastin->DG/Avastin

DG/Avastin

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Time to Tumor Progression

Overall Survival

Quality of life assessment

Full Information

NCT ID

NCT00620971

First Posted

January 31, 2008

Last Updated

June 24, 2014

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00620971

Brief Title

Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

Official Title

Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (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 whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.

Detailed Description

An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic 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

Non Small Cell Lung Cancer, Cisplatin, VInorelbine, Docetaxel, Gemcitabine, Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

NC/Avastin->DG/Avastin

Arm Title

Arm Type

Experimental

Arm Description

DG/Avastin

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Other Intervention Name(s)

Navelbine

Intervention Description

Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Primary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to Tumor Progression

Time Frame

1-year

Title

Overall Survival

Time Frame

1 year

Title

Quality of life assessment

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC Performance status (WHO) 0-1 Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min) No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed --Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm Patient able to take oral medication Absence of active CNS disease Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available Patients must be able to understand the nature of this study and give written informed consent Exclusion Criteria: Pregnant or lactating women Women of child-bearing age unable or unwilling to take effective contraceptive measures Active CNS disease, brain metastases, or leptomeningeal involvement Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0) Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months Active infection, requiring IV antibiotic treatment, within the previous 2 weeks Long-term oxygen therapy Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer Radiotherapy within the previous 4 weeks Previous radiotherapy to the only measurable lesion Concurrent treatment with other anti-cancer drug Uncontrolled hypercalcemia Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or equivalent) for more than one month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vassilis Georgoulias, 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

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

City

Athens

Country

Greece

Facility Name

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

401 Military Hospital, Medical Oncology Unit

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital, Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

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

City

Athens

Country

Greece

Facility Name

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

City

Athens

Country

Greece

Facility Name

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

City

Athens

Country

Greece

Facility Name

"Theagenion" Anticancer Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

25662596

Citation

Kotsakis A, Kentepozidis N, Emmanouilidis Ch, Polyzos A, Agelidou A, Vaslamatzis M, Chandrinos V, Agelaki S, Vamvakas L, Kalbakis K, Katsaounis P, Stoltidis D, Nintos G, Hatzidaki D, Vetsika EK, Mavroudis D, Georgoulias V. Sequential administration of vinorelbine plus cisplatin and bevacizumab followed by docetaxel plus gemcitabine and bevacizumab compared to docetaxel plus cisplatin and bevacizumab regimen as first-line therapy for advanced or metastatic non-squamous non-small cell lung cancer: A multicenter randomized phase II trial of the Hellenic Oncology Research Group (HORG). Lung Cancer. 2015 Apr;88(1):57-62. doi: 10.1016/j.lungcan.2015.01.012. Epub 2015 Jan 23.

Results Reference

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Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

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