Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741221
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):
Hellenic Oncology Research Group

August 25, 2008
August 26, 2008
October 4, 2016
June 2008
October 2016   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00741221 on Archive Site
  • Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]
  • Overall Survival [ Time Frame: 1 year ]
  • Quality of life assessment [ Time Frame: Assessment every two cycles ]
  • Toxicity profile [ Time Frame: Assessment every two cycles ]
Same as current
Not Provided
Not Provided
Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer
Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer (NSCLC).
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small-cell Lung Cancer
  • 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
Experimental: 1
  • Drug: Pemetrexed
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2016
October 2016   (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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hellenic Oncology Research Group
Hellenic Oncology Research Group
Not Provided
Principal Investigator: Sofia Agelaki, MD University Hospital of Crete, Dep of Medical Oncology
Principal Investigator: Manolis Kontopodis, MD University Hospital of Crete
Hellenic Oncology Research Group
October 2016

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