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

• Conditions: metastatic non-squamous non-small-cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IV

• Registration Number: EUCTR2010-022104-50-NL
• Lead Sponsor: Stichting NVALT Studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

•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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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.
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
•Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
•Radiotherapy within 4 weeks of start of study drug. Palliative radiotherapy for bone lesions is allowed > 14 days of start of chemotherapy. Major surgery within 4 weeks of start of study.
•Use of vasodilators (including 5-fosfodiesterase inhibitors, calcium antagonists or nitrates)
•Autologous bone marrow transplant or stem cell rescue within 4 months of study
•Investigational drug therapy outside of this trial during or within 4 weeks of study entry
•Pregnancy or lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified