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Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Carboplatin
Bevacizumab
Paclitaxel
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
  • Non-squamous histologic type
  • At least one and no more than two previous chemotherapy regimens for advanced or 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 ≥ 9 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:

  • Previous therapy with paclitaxel in combination with carboplatin
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical 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)
  • Symptomatic neuropathy > 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

Sites / Locations

  • University Hospital of Heraklion, Dep of Medical Oncology
  • University General Hospital of Alexandroupolis
  • "IASO" General Hospital of Athens, 1st 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 of Athens
  • Air Forces Military Hospital of Athens
  • State General Hospital of Larissa, Dep of Medical Oncology
  • "Diabalkaniko" hospital, Thessaloniki
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Paclitaxel/Carboplatin/Bevacizumab

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Toxicity profile
Time to Tumor Progression
Overall Survival

Full Information

First Posted
September 16, 2008
Last Updated
October 3, 2016
Sponsor
Hellenic Oncology Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00753909
Brief Title
Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
Official Title
Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, advanced non small cell lung cancer.
Detailed Description
The addition of bevacizumab to paclitaxel plus carboplatin in the 1st line treatment of patients with advanced or metastatic non small cell lung cancer (NSCLC) provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. The combination of paclitaxel and carboplatin, administered every two weeks, has a favorable toxicity profile. This study will evaluate the addition of bevacizumab to a biweekly regimen of paclitaxel and carboplatin as 2nd or 3rd line therapy for 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, Paclitaxel, Carboplatin, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Paclitaxel/Carboplatin/Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxoprol, Paxene, Taxol
Intervention Description
Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 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
Toxicity profile
Time Frame
Toxicity assessment of each chemotherapy cycle
Title
Time to Tumor Progression
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
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC Non-squamous histologic type At least one and no more than two previous chemotherapy regimens for advanced or 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 ≥ 9 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: Previous therapy with paclitaxel in combination with carboplatin Second primary malignancy, except for non-melanoma skin cancer and in situ cervical 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) Symptomatic neuropathy > 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Agelaki, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Heraklion, Dep of Medical Oncology
City
Heraklion
State/Province
Creta
Country
Greece
Facility Name
University General Hospital of Alexandroupolis
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
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
"Diabalkaniko" hospital, Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer

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