Lungcancer
Conditions
Interventions
Patients will be treated with Bevacizumab and Erlotinib
Bevacizumab: 15 mg/kg i.v. on day 1 of each 3-week cycle
Erlotinib: 150 mg p.o., daily
Treatment will be given until disease progression.
Sponsors
European Thoracic Oncology Platform
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Age * 18 years -ECOG performance status 0-2 -Adequate haematological function: haemoglobin > 9 g/dL, neutrophils count > 1.5 x 109/L, platelet count > 100 x 109/L -Adequate coagulation: INR * 1.5 -Adequate liver function: Total bilirubin
Exclusion criteria
Exclusion criteria: -Not eligible: patients with increased risk of bleeding, defined by: a. major surgery or significant traumatic injury within 28 days prior to inclusion b. minor surgery (including permanent catheter insertion) within 24 hours prior to first treatment with bevacizumab c. history or evidence of bleeding diathesis or hereditary coagulopathy d. history of haemoptysis (defined as at least half a teaspoon's emission or red blood) in the 3 months prior to inclusion e. evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels f. uncontrolled hypertension (systolic blood pressure > 150 mm Hg and/or diastolic > 100 mm Hg) -Not eligible: patients with clinically significant cardiovascular diseases, including a. cerebral vascular accident ( NYHA II e. serious cardiac arrhythmia requiring medication during the study and which could interfere with regularity of study treatment or is not controlled with medication -Not eligible: patients with a history of thrombosis or thromboembolism in the 6 months prior to treatment -Not eligible: patients with gastrointestional problems including a. intestinal transit problems (such as malabsorption syndrome, chronic intestinal inflammatory disease, or other pathologies that can alter absorption of the medication b. history of abdominal fistula, intestinal perforation or intra-abdominal abscess within 6 months prior to inclusion c. uncontrolled active peptic ulcer d. presence of trachea-oesophageal fistula -Not eligible: patients with neurologic problems, including a. evidence of spinal cord compression b. significant neurological or psychiatric disorders (including dementia and epileptic seizures) -Not eligible: Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma -Not eligible: patients with known significant ophthalmologic anomaly of the ocular surface. The use of contact lenses is not recommended -Not eligible: patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the study -Not eligible: Known hypersensitivity to bevacizumab or erlotinib or any of its excipients -Not eligible: patients who received prior chemotherapy for metastatic disease. Patients with prior neoadjuvant or adjuvant chemotherapy or definitive radiochemotherapy for localised disease are eligible if chemotherapy has stopped at least 6 months before entering the study -Not eligible: patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF. Patients with previous intraocular treatment with VEGF-targeting drugs are eligible -Not eligible: patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study -Not eligible: patients with current or recent use (within the last 10 days) of full doses of anticoagulants or thrombolytics, either orally or parenterally. Use of anticoagulant prophylaxis is permitted (low dose heparin or aspirin * 325
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure, overall survival, objective respons rate, disease control rate, duration of response, toxicity. | — |
Countries
Netherlands
Outcome results
None listed