Status:
TERMINATED
Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Genentech, Inc.
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE1
PHASE2
Brief 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 III...
Detailed Description
This is a Phase I/II trial of elderly patients (\> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00351039
Start Date
July 1 2006
End Date
September 1 2008
Last Update
March 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612