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Small Cell Lung CancerPhase 2NCT00755157

Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

A Phase 2 study testing Docetaxel and Bevacizumab in people with Small Cell Lung Cancer, run by University Hospital of Crete at 3 sites in Greece.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Docetaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesGreece
Study dates
Apr 2008to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

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

    Athens

  • University Hospital of Crete, Dep of Medical Oncology

    Heraklion, Crete

Other trials in Greece

About this study

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)

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

Read the 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.

Being tested
Docetaxel, Bevacizumab
Keywords
Cancer, SCLC, Docetaxel, Bevacizumab, Chemotherapy
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

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

  • BevacizumabDrug

    Also called Avastin

    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

Study groups in NCT00755157
Study groupRoleWhat they receive
1ExperimentalDocetaxel(metronomic)/Bevacizumab
Receives: Drug: Docetaxel; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: up to 6 months

Secondary outcomes (4)

  1. Progression free survival

    Measured: 1 year

  2. Toxicity profile

    Measured: Toxicity assessment at every cycle

  3. Overall Survival

    Measured: 1 year

  4. Quality of life assessment

    Measured: Assessment every two cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00755157
Sponsor's protocol ID
CT/08.06
Status last verified
Oct 2015
First submitted
17 Sep 2008
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Bevacizumab in people with Small Cell Lung Cancer, run by University Hospital of Crete at 3 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00755157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.

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