A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) - VITA
- Conditions
- Patients treated with second-line docetaxel after failure of one platinum based therapy for locally advanced or metastatic non-small-cell lung cancer (NSCLC).
- Registration Number
- EUCTR2007-000819-29-GB
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 910
- Histological/cytological proven locally advanced or metastatic non-small cell lung cancer.
- Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based (chemotherapy or targeted therapy) for advanced or metastatic disease. Disease progression within 6 months of adjuvant platinum-based chemotherapy is accepted.
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
- Related to the methodology
• Squamous histology/cytology
• Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization. Less than 42 days elapsed from prior major surgery (lung resection) to the time of randomization.
• Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy
to > 25% of bone marrow
• Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.
• Age <18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2.
• History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
• History of another neoplasm. Adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for > 5 years are allowed.
• Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
• Any of the following events within the 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
• Any of the following events within the 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
• Occurrence of deep vein thrombosis within 4 weeks, prior to randomization.
• Acquired immunodeficiency syndrome (AIDS-related illnesses)or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment
• Any severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study or interfere with interpretation of study results.
• Absence of signed and dated Institutional Review Board (IRB)- approved patient informed consent form prior to enrollment into the study.
• Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization.
• Patient with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment.
- Related to aflibercept
• History of prior discontinuation of any anti-VEGF agent due to adverse drug reaction.
• Urine protein:creatinine ratio (UPCR) > 1 on morning spot urinalysis or proteinuria > 500 mg/24h.
• Serum Creatinine > 1.5 x ULN (if creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated according to Cockroft-Gault formula < 60 mL/min will exclude the patient).
• Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg (grade = 2 according to NCI CTCAE v.3.0), or systolic blood pressure >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days, within 3 months prior to study randomization.
• Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range INR (>3) within 4 weeks prior to randomization.
• Evidence of clinic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).;Secondary Objective: -To compare efficacy of aflibercept to placebo for:<br> • Progression Free Survival (PFS),<br> • Response Rate (RR) as per RECIST criteria (JNCI 2000),<br> • Health Related Quality of Life (HRQL) assessed by the Lung cancer symptom scale (LCSS) questionnaire<br><br>- To assess the overall safety of the two treatment arms.<br><br>- To assess the pharmacokinetics of intravenous (IV) aflibercept in this patient population.<br><br>- To determine immunogenicity of IV aflibercept (anti- aflibercept antibody detection) in all patients.;Primary end point(s): Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause.
- Secondary Outcome Measures
Name Time Method