Clinical trial NCT00354549 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bevacizumab + erlotinib hydrochloride, gemcitabine hydrochloride + cisplatin or carboplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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