Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer

NCT ID: NCT00741195

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2016-10-31

Brief Summary

This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (NSCLC).

Detailed Description

Docetaxel is and an effective cytotoxic agent in > 1st line treatment of advanced or metastatic non small cell lung cancer (NSCLC). 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. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of docetaxel and bevacizumab as 2nd or 3rd line treatment of NSCLC.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Docetaxel/Bevacizumab

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel at the dose of 75 mg/m2 IV on days 1 every 3 weeks for 6 consecutive cycles.

Bevacizumab

Intervention Type: DRUG

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Interventions

Docetaxel

Docetaxel at the dose of 75 mg/m2 IV on days 1 every 3 weeks for 6 consecutive cycles.

Intervention Type: DRUG

Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Taxotere; Avastin

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed,
• Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
• At least one and no more than two previous chemotherapy regimens for advanced - or metastatic NSCLC
• 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

• Previous therapy with docetaxel
• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical 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)
• Symptomatic neuropathy > 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lampros Vamvakas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Athanasios Karampeazis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University Hospital of Heraklion

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, , Greece

401 Military Hospital, Medical Oncology Unit

Athens, , Greece

Air Forces Military Hospital, Dep of Medical Oncology

Athens, , Greece

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

Athens, , Greece

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, , Greece

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

Athens, , Greece

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Piraeus, , Greece

Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/08.09

Identifier Type: -

Identifier Source: org_study_id