Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer

NCT00741195 | Completed Phase 2

• 1 other identifier: CT/08.09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

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).

Conditions

Non-small-cell Lung Cancer

Keywords

Cancer; NSCLC; Docetaxel; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  1 year

Secondary Outcomes (4)

• Overall response rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

• Overall Survival

  1 year

• Quality of life assessment

  Assessment every two cycles

• Toxicity profile

  Assessment every two cycles

Study Arms (1)

1

EXPERIMENTAL

Docetaxel/Bevacizumab

Drug: Docetaxel; Drug: Bevacizumab

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

1

Bevacizumab DRUG

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

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (10)

University Hospital of Heraklion

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

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

Athens, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

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

Piraeus, Greece

Location

Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Docetaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lampros Vamvakas, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Athanasios Karampeazis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

GR (10)