Status:
COMPLETED
Paclitaxel-Carboplatin-Bevacizumab +/- Nitroglycerin in Metastatic Non-Squamous-Non-Small Cell Lung Cancer
Lead Sponsor:
Dutch Society of Physicians for Pulmonology and Tuberculosis
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery 25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small cell lung can...
Detailed Description
Standard treatment for non-small cell lung cancer (NSCLC) consists of platinum-containing chemotherapy. It has been shown that the addition of bevacizumab to standard chemotherapy improves progression...
Eligibility Criteria
Inclusion
- 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. epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI), 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.
- 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.
Exclusion
- 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-phosphodiesterase 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01171170
Start Date
January 1 2011
End Date
August 1 2020
Last Update
September 28 2020
Active Locations (8)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
VU medisch centrum
Amsterdam, Netherlands
3
Amphia Ziekenhuis
Breda, Netherlands
4
Catharina-Ziekenhuis
Eindhoven, Netherlands