Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

University Hospital of Crete

Status and phase

Withdrawn

Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Docetaxel

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00755157

CT/08.06

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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