Pemetrexed Plus Bevacizumab in 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:
NCT00741221
First received: August 25, 2008
Last updated: June 21, 2014
Last verified: June 2014
  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 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: Pemetrexed 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: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pemetrexed/Bevacizumab
Drug: Pemetrexed
Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: Alimta
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
Other Name: Avastin

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00741221     History of Changes
Other Study ID Numbers: CT/08.10
Study First Received: August 25, 2008
Last Updated: June 21, 2014
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
Bevacizumab
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 16, 2014