Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively and Prospectively as First Line Treatment for Patients With Advanced or Metastatic Non Small Cell Lung Cancer. Assessment of Toxicity, Compliance and Survival of Patients.

Hellenic Oncology Research Group8 sites in 1 country300 target enrollmentFebruary 2010

ConditionsNon Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non Small Cell Lung Cancer
Sponsor: Hellenic Oncology Research Group
Enrollment: 300
Locations: 8
Primary Endpoint: Number of Participants with AE
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer.

All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung Cancer.

Detailed Description

In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, progression free survival and estimation of overall survival

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

December 2013

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hellenic Oncology Research Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent prior to initiation of any trial-specific procedure or treatment
•Ability to comply with the protocol
•Histologically or cytologically (sample to be obtained by biopsy or bronchoscopy) confirmed non-squamous NSCLC (locally recurrent or metastatic) per investigator assessment
•At least 1 unidimensionally measurable lesion meeting RECIST criteria
•No prior first line treatment for metastatic colorectal cancer
•Age ≥18 years
•ECOG performance status ≤2
•Adequate haematological, renal and hepatic function
•Urine protein \<2+ (dipstick)
•International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN within 7 days prior to randomization, unless there is prophylactic use of anti-coagulation

Exclusion Criteria

•Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
•History of hemoptysis ≥ grade 2 (defined as bright red blood of at least 2.5 mL) within 3 months prior to randomization
•Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during trial treatment
•Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
•Evidence of tumor invading or abutting a major blood vessel (e.g., pulmonary artery or superior vena cava) on imaging
•Radiotherapy to any site for any reason within 28 days prior to randomization. Palliative radiotherapy to bone lesions within 14 days prior to randomization is allowed
•Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose (i.e. therapeutic dose) oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
•History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding
•Active gastrointestinal bleeding
•Inadequately controlled hypertension (blood pressure: systolic \> 150 mmHg and/or diastolic \> 100 mmHg) within 28 days prior to randomization or history of hypertensive crisis or hypertensive encephalopathy