Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00741195
First received: August 25, 2008
Last updated: June 21, 2014
Last verified: June 2014

August 25, 2008
June 21, 2014
April 2008
December 2014   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741195 on ClinicalTrials.gov Archive Site
  • Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer
Docetaxel Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small-cell Lung Cancer
  • Drug: Docetaxel
    Docetaxel at the dose of 75 mg/m2 IV on days 1 every 3 weeks for 6 consecutive cycles.
    Other Name: Taxotere
  • Drug: Bevacizumab
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
    Other Name: Avastin
Experimental: 1
Docetaxel/Bevacizumab
Interventions:
  • Drug: Docetaxel
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Sofia Mavraki +302810392987 maurakh@gmail.com
Greece
 
NCT00741195
CT/08.09
No
Hellenic Oncology Research Group
Hellenic Oncology Research Group
Not Provided
Principal Investigator: Lampros Vamvakas, MD University Hospital of Crete, Dep of Medical Oncology
Principal Investigator: Athanasios Karampeazis, MD University Hospital of Crete
Hellenic Oncology Research Group
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP