Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00741221

Purpose

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

Condition	Intervention	Phase
Non-Small-Cell Lung Cancer	Drug: Pemetrexed Drug: Bevacizumab	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Pemetrexed disodium Pemetrexed Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

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:	June 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pemetrexed/Bevacizumab	Drug: Pemetrexed Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles Drug: Bevacizumab Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles After the end of the 6 cycles Bevacizumab will be administered alone at the dose of 15 mgr/Kgr (IV) every 3 weeks until disease progression

Detailed Description:

Pemetrexed is and an effective and well tolerated cytotoxic agent in the 2nd 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 pemetrexed 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 pemetrexed
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: NCT00741221

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+302810392987	dorachat@med.uoc.gr

Locations

Greece
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
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
"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
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
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
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
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
"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
Greece, Crete
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

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:	Sofia Agelaki, MD	University Hospital of Crete, Dep of Medical Oncology
Principal Investigator:	Manolis Kontopodis, MD	University Hospital of Crete

More Information

Responsible Party:	Hellenic Oncology Research Group ( S.Agelaki )
Study ID Numbers:	CT/08.10
Study First Received:	August 25, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741221
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Cancer
NSCLC
Docetaxel
Bevacizumab

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Folic Acid Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009