BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

Inclusion Criteria

• Age = 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
• Life expectancy of at least 12 weeks at the pre-treatment evaluation
• Patients with metastatic, measurable, histologically or cytologically documented NSCLC (includes squamous, large cell or adenocarcinoma). In case of unique metastatic site, histological confirmation is required in order to ensure proper diagnosis prior to study entry
• Patients must have progressive non-small cell lung cancer (NSCLC)
• No more than 2 prior systemic agent or regimen at least 28 days prior to study entry. (Prior therapy with gefitinib is allowed but not mandatory)
• Patients must be considered appropriate for systemic anti-cancer therapy by the Investigator
• Patients with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Adequate bone marrow, liver and renal function, as assessed by the following laboratory:
• Hemoglobin = 9.0 g/dl
• Absolute granulocytes = 1.5 x 10E9/L
• Platelet count = 100 x 10E9/L
• Total bilirubin New York Heart Association (NYHA) Class II
• Uncontrolled hypertension
• Complete renal shut-down requiring hemo- or peritoneal dialysis
• Mixed histologies
• Active clinically serious infections (> grade 2 on the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0)
• Known history of HIV infection or chronic hepatitis B or C
• Known metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. A head CT or MRI must be conducted to rule out brain metastasis or meningeal tumors. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided that the dose is stable for one month prior to and following screening radiographic studies)
• History of seizure disorder requiring medication (such as steroids or anti-epileptics)
• History of organ allograft and bone marrow transplant
• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis & T1] or other malignancies curatively treated > 3 years prior to entry)
• Patients with clinically significant bleeding (e.g., gastrointestinal bleeding) within the past month prior to study entry are ineligible
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (e.g. cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between BAY 43-9006 and oral contraceptives
• Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patients participation in the study or evaluation of the study results
• Known allergy to the investigational agent or any agent given in association with this trial
• Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment
• Anti cancer chemotherapy, immunotherapy, vaccines or investigational therapy during the study or within 4 weeks of study entry.
• Radiotherapy during the study or within 4 weeks of study entry. Patients must have recovered from radiation-induced toxicity. However, palliative is allowed for local pain control.
• Any surgical procedure within 4 weeks prior to the start of study drug. Autologous and/or allogenic including mini-allogenic bone marrow transplant or st