Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00755157
• Other study ID #: CT/08.06
• Status: Withdrawn
• Phase: Phase 2
• First received: September 17, 2008
• Last updated: October 6, 2015
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2015
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ?a+ < 120 mg/dL

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		up to 6 months	No
Secondary	Progression free survival		1 year	No
Secondary	Toxicity profile		Toxicity assessment at every cycle	Yes
Secondary	Overall Survival		1 year	No
Secondary	Quality of life assessment		Assessment every two cycles	No