Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) Newly diagnosed or recurrent disease Meets 1 of the following staging criteria: Stage IIIB disease, meeting both of the following criteria: Proven malignant effusion or supraclavicular node involvement (i.e., N3 supraclavicular nodes) Not a candidate for curative multimodality treatment or surgery Stage IV disease Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI Immediate chemotherapy not clinically mandatory in the judgement of the investigator No intrathoracic large, centrally located tumors and/or cavitary lesions invading or abutting major blood vessels No evidence of clinically active interstitial lung disease Patients with chronic stable radiographic changes who are asymptomatic are eligible No small cell lung cancer (SCLC), squamous NSCLC, or combined SCLC-NSCLC tumors No brain metastases PATIENT CHARACTERISTICS: WHO performance status 0-1 Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 1,500/mm³ Thrombocyte count ≥ 100,000/mm³ Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present) Quick ≥ 70% OR INR ≤ 1.5 Creatinine ≤ 2.0 times ULN Proteinuria ≤ 2+ by urine dipstick Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment Able to understand trial information given by the investigator and complete quality of life questionnaire No pre-existing condition that would preclude swallowing and/or absorption of oral medication No prior or concurrent malignancies, except for the following: Malignancy for which the minimum relapse-free interval is ≥ 5 years Nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No other medical condition that would preclude study participation, including any of the following: Unstable or uncompensated respiratory, cardiac, hepatic, or renal disease Active infection Uncontrolled diabetes mellitus Hypertension ≥ 150/100 mm Hg despite treatment Myocardial infarction within the past 3 months History of hemorrhagic disorders Non-healing wound, ulcer, or bone fracture No clinical history of coagulopathy or thrombosis No hemoptysis or hematemesis ≥ grade 2 (defined as bright red blood of ≥ 5 mL per episode) within the past 6 months No known hypersensitivity to study drug(s) or to any other component of the study drugs No significant traumatic injury within the past 28 days No serious underlying medical condition that would impair the ability of the patient to participate in the trial or that would preclude use of study drugs No cerebrovascular accident or other CNS bleeding within the past 6 months PRIOR CONCURRENT THERAPY: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to lesion(s) selected for measurement No prior chemotherapy for advanced disease At least 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC Prior intrapleural or intrapericardial local chemotherapy allowed No prior endothelial growth factor and/or vascular endothelial growth factor (receptor)-targeted therapy for NSCLC More than 28 days since prior major surgical procedure or open biopsy More than 30 days since prior treatment in another clinical trial No concurrent anticoagulants (e.g., phenprocoumon, acenocoumarol, or full-dose warfarin or heparin) No concurrent full-dose continuous use of non-steroid anti-inflammatory drugs (NSAIDs) No concurrent aspirin or clopidogrel bisulfate Low-dose aspirin (≤ 325 mg daily) may be continued in patients at high risk for arterial thromboembolic disease No other concurrent drugs contraindicated for use with the study drugs, according to the Swissmedic-approved product information No other concurrent experimental drugs or anticancer therapy, including chemotherapy, immunotherapy, or hormone therapy
Sites / Locations
- Universitaetsspital-Basel
- Oncology Institute of Southern Switzerland