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Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Open (Enrolling)
Non-small-cell Lung Cancer

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Trial Information

Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic 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

Inclusion Criteria:

- Histologically or cytologically confirmed,

- Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous

- 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

- 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

- Pregnant or lactating women

- Any serious, uncontrolled comorbidity on the investigator's judgment. Uncontrolled

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Sofia Agelaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

June 2008

Completion Date:

March 2013

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Cancer
  • Docetaxel
  • Bevacizumab
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms