Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer
This is a Phase I/II trial of elderly patients (\> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed\[Alimta™\], Bevacizumab and Erlotinib\[Tarceva™\]) which are given every 28 days.
Checked against the public recordLast updated Mar 23, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Interventions being studied
- Drug: Bevacizumab; Drug: Erlotinib; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Patient must have histologically proven diagnosis of Non-Squamous NSCLC. NSCLC histologies that will be included in this trial will be adenocarcinoma, large cell carcinoma and adeno-squamous carcinoma. Patients with bronchioloalveolar carcinoma (BAC) will be also included in this trial. * Patients must be 70 years of age or older. * Patient must have either stage IIIB disease with malignant pleural effusion or stage IV disease. All patients must have measurable disease. Evaluable disease will be separately outlined and elucidated. * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1. * Patient must have adequate renal function with a serum creatinine level of less than 1.5mg/dl and patient should have a calculated creatinine clearance of more than 45ml/min. * Patient must have adequate hepatic function with a serum bilirubin level of less that 3mg/dl, and an alkaline phosphatase, Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) of less than three times the upper limit of normal * Patient must also have evidence of adequate bone marrow function with an absolute neutrophil count of more than 1, 500 cells per deciliter and a platelet count of more than 100,000 per deciliter. * Patients must be more than 28 days since prior open biopsy; more than 7 days since prior fine-needle aspiration; more than 7 days since prior core biopsy; more than 28 days since prior surgery. * Patients must be able to take dexamethasone, folic acid and vitamin B-12 supplementation. * All patients must sign informed consent that will detail the investigational nature of the study in accordance with the institutional and federal guidelines. Exclusion Criteria: * Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, with or without cavitation. * Patients with hypercalcemia (corrected calcium of more than 11 mg/dl) will be excluded. * Patients with history of hemoptysis, hematemesis, coagulopathy or thrombosis will be excluded. * Patients requiring anticoagulation for any reason will be excluded. * Patients who recently have an acute infection. * History of palliative radiation therapy within 2 weeks. * Blood pressure of \>150/100 Millimeter Mercury(mmHg). * Currently ongoing unstable angina. * New York Heart Association (NYHA) Grade II or greater congestive heart failure. * History of myocardial infarction within 6 months. * History of stroke within 6 months. * Clinically significant peripheral vascular disease. * Presence of central nervous system or brain metastases. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study. * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0. * Pregnant (positive pregnancy test) or lactating. * Urine calculated creatinine clearance of less than 45ml/minute and a urinary protein. Creatinine ratio of more than 1. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1. * Serious, non-healing wound, ulcer, or bone fracture. * Inability to comply with study and/or follow-up procedures.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 23, 2017. Always confirm current availability with the study team.