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Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer.
This study has been terminated.
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Genentech
Eli Lilly and Company
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00351039
  Purpose

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 will be enrolled. Therapy consists of three drugs (Alimta, Bevacizumab and Tarceva) given every 28 days. Alimta * Bevacizumab are given days 1 & 15 and Tarceva are given for 7 days starting on days 2 and 15.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Bevacizumab
Drug: Erlotinib
Drug: Pemetrexed
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Pemetrexed disodium Pemetrexed Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC).

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival (median survival(MS) and 1-yr survival(1-yr S)) [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]
  • Quality of Life (QOL) [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Single arm phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
Drug: Bevacizumab Drug: Erlotinib Drug: Pemetrexed

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 will be enrolled.

Treatment Regimen:

Alimta 500mg/m2 I.V. Day 1 and Day 15 Bevacizumab 10mg/Kg I. V. Day 1 and Day 15 Tarceva 150mg PO QD for 7 days starting day 2 and day 15 Repeat cycles every 28 days.

All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Tarceva until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment withBevacizumab and Tarceva is initiated.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, ALT and 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 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 28days 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351039

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Genentech
Eli Lilly and Company
Investigators
Principal Investigator: George Simon, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Moffiitt Cancer Center Clinical Trials Website  This link exits the ClinicalTrials.gov site

Responsible Party: H. Lee Moffitt Cancer Center & Research Institute ( George Simon, M.D. )
Study ID Numbers: MCC-14659
Study First Received: July 11, 2006
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00351039  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Pleural Diseases
Pleural Effusion, Malignant
Bevacizumab
Carcinoma
Folic Acid
Pemetrexed
Pleural Effusion
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Pleural Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009