A randomized phase II study of paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV non-squamous-non-small cell lung cancer: NVALT12 - NVALT12

Stichting NVALT Studies0 sites222 target enrollmentJuly 30, 2010

Overview

No summary available.

Registry

who.int

Start Date

July 30, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Stichting NVALT Studies

•Histologically/cytologically proven stage IV non\-squamous NSCLC (according to IASLC staging 7\.0\)
•No prior chemotherapy or therapy with systemic anti\-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy \> 1 year ago and prior treatment with an EGFR\-TKI for patients with an activating EGFR mutation is allowed.
•Age \= 18 years.
•ECOG Performance Status of 0 – 2\.
•Life expectancy of at least 12 weeks.
•Subjects with at least one uni\-dimensional(for RECIST) measurable lesion.
•Adequate bone marrow, liver and renal function (see protocol for details).
•Adequate non\-hormonal contraception for females of childbearing potential during the study and in the 6 months thereafter.
•Adequate contraception for male participants (or their partners) during the study and in the 6 months thereafter.
•Are the trial subjects under 18? no

•Clinically significant (i.e. active) cardiovascular disease: congestive heart failure \>NYHA class 2; CVA or myocardial infarction \< 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic \> 150 mmHg and/or diastolic \> 100 mmHg).
•Symptomatic hypotension.
•History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
•Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery).
•History of HIV infection or chronic hepatitis B or C.
•Active clinically serious infection
•Symptomatic metastatic brain or meningeal tumors. Patients with brain metastasis may be included the patient is treated with brain radiotherapy and asymptomatic.
•History of organ allograft.
•Patients with evidence or history of bleeding diathesis.
•Non\-healing wound or ulcer.