NCT00755157

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

4.3 years

First QC Date

September 17, 2008

Last Update Submit

October 6, 2015

Conditions

Small Cell Lung Cancer

Keywords

CancerSCLCDocetaxelBevacizumabChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    up to 6 months

Secondary Outcomes (4)

  • Progression free survival

    1 year

  • Toxicity profile

    Toxicity assessment at every cycle

  • Overall Survival

    1 year

  • Quality of life assessment

    Assessment every two cycles

Study Arms (1)

1

EXPERIMENTAL

Docetaxel(metronomic)/Bevacizumab

Drug: DocetaxelDrug: Bevacizumab

Interventions

DocetaxelDRUG

Metronomic docetaxel (IV) 30 mg/m2 on days 1, 8, 15 every 4 weeks for 6 cycles maximum

Also known as: Taxotere
1
BevacizumabDRUG

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

Also known as: Avastin
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

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

Athens, Greece

Location

MeSH Terms

Conditions

Small Cell Lung CarcinomaNeoplasms

Interventions

DocetaxelBevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sofia Agelaki, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

GR(3)