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Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Docetaxel

Bevacizumab

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Cancer, SCLC, Docetaxel, 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) small cell lung cancer
One previous chemotherapy regimen metastatic SCLC
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 and give 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+ < 120 mg/dL

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Docetaxel(metronomic)/Bevacizumab

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Progression free survival

Toxicity profile

Overall Survival

Quality of life assessment

Full Information

NCT ID

NCT00755157

First Posted

September 17, 2008

Last Updated

October 6, 2015

Sponsor

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00755157

Brief Title

Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Withdrawn

Study Start Date

April 2008 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Approximately 80% of the patients with localized SCLC and all of the patients with extensive SCLC will relapse after 1st line chemotherapy. For the chemo-resistant patients (eg those that have relapsed during or less than 3 months after 1st line chemotherapy the sole agent approved for 2nd line chemotherapy is topotecan. Docetaxel has shown some activity as 1st line treatment (ORR 17%). 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. A number of phase II studies are currently evaluating the addition of bevacizumab to 1st line chemotherapy in SCLC patients with promising results of safety and efficacy. Given the poor results of 2nd line chemotherapy in SCLC we feel that the evaluation of the combination of metronomic docetaxel and bevacizumab (2 anti-angiogenic agents) in such patients is justified. This study will evaluate the combination of metronomic docetaxel and bevacizumab as 2nd line treatment of SCLC.

6. Conditions and Keywords

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

Small Cell Lung Cancer

Keywords

Cancer, SCLC, Docetaxel, 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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Docetaxel(metronomic)/Bevacizumab

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Metronomic docetaxel (IV) 30 mg/m2 on days 1, 8, 15 every 4 weeks for 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 (not compulsory) Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression

Primary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

1 year

Title

Toxicity profile

Time Frame

Toxicity assessment at every cycle

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

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed, metastatic (stage IV) small cell lung cancer One previous chemotherapy regimen metastatic SCLC 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 and give 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+ < 120 mg/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 Hospital of Crete, Dep of Medical Oncology

City

Heraklion

State/Province

Crete

Country

Greece

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

12. IPD Sharing Statement

Learn more about this trial

Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

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