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

Phase 2
18 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

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

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

Inclusion Criteria:

- Histologically or cytologically confirmed, metastatic (stage IV) small cell lung

- One previous chemotherapy regimen metastatic SCLC

- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

up to 6 months

Safety Issue:


Principal Investigator

Sofia Agelaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

April 2008

Completion Date:

December 2012

Related Keywords:

  • Small Cell Lung Cancer
  • Cancer
  • SCLC
  • Docetaxel
  • Bevacizumab
  • Chemotherapy
  • Lung Neoplasms
  • Small Cell Lung Carcinoma