Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer
This study is currently recruiting participants.
Verified September 2012 by Hellenic Oncology Research Group
Sponsor:
Hellenic Oncology Research Group
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00741195
First received: August 25, 2008
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (NSCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small-cell Lung Cancer |
Drug: Docetaxel Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Docetaxel Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Docetaxel/Bevacizumab
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741195
Contacts
| Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
| Contact: Sofia Mavraki | +302810392987 | maurakh@gmail.com |
Locations
| Greece | |
| University Hospital of Heraklion | Recruiting |
| Heraklion, Crete, Greece | |
| Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
| Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
| Sub-Investigator: Manolis Kontopodis, MD | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | Recruiting |
| Alexandroupolis, Greece | |
| Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
| Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
| Principal Investigator: Stelios Kakolyris, MD | |
| Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Foteini Apostolopoulou, MD | |
| Principal Investigator: Vassilis Xandrinos, MD | |
| Air Forces Military Hospital, Dep of Medical Oncology | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Nikos Kentepozidis, MD | |
| IASO" General Hospital of Athens, 1st Dep of Medical Oncology | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Stelios Giassas, MD | |
| Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Athina Aggelidou, MD | |
| Principal Investigator: Anna Xrhstou, MD | |
| Principal Investigator: Ourania Anagnostopoulou, MD | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Aris Polyzos, MD | |
| 401 Military Hospital, Medical Oncology Unit | Recruiting |
| Athens, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Charalambos Christophillakis, MD | |
| "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | Recruiting |
| Piraeus, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Nikos Ziras, MD | |
| Theagenion" Anticancer Hospital of Thessaloniki | Recruiting |
| Thessaloniki, Greece | |
| Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr | |
| Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
| Principal Investigator: Ioannis Boukovinas, MD | |
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
| Principal Investigator: | Lampros Vamvakas, MD | University Hospital of Crete, Dep of Medical Oncology |
| Principal Investigator: | Athanasios Karampeazis, MD | University Hospital of Crete |
More Information
No publications provided
| Responsible Party: | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00741195 History of Changes |
| Other Study ID Numbers: | CT/08.09 |
| Study First Received: | August 25, 2008 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Cancer NSCLC Docetaxel Bevacizumab |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Docetaxel Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013