Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Eli Lilly and Company; Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride; Pemetrexed

Criteria

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.