Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer

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

Detailed Description
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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.

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

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Pemetrexed
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pemetrexed/Bevacizumab | Drug: Pemetrexed<br>* Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles<br>* Other names: Alimta;Drug: Bevacizumab<br>* 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<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Overall Survival |  | 1 year | 
| Quality of life assessment |  | Assessment every two cycles | 
| Toxicity profile |  | Assessment every two cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, NSCLC, Docetaxel, Bevacizumab