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

NCT00351039 | Terminated Phase 1 Results DMC

• 1 other identifier: MCC-14659
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.

  26 months

Secondary Outcomes (5)

• One-year Survival(1-year S)

  26 Months

• Number of Patients Who Responded to Treatment

  26 Months

• Quality of Life (QOL)

  26 Months

• Number of Participants With Grade 3 and Grade 4 Adverse Events

  26 Months

• Overall Survival (Median Survival [MS])

  26 Months

Study Arms (1)

Bevacizumab, Erlotinib, Pemetrexed

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

Interventions

Bevacizumab DRUG

Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.

Also known as: Avastin

Bevacizumab, Erlotinib, Pemetrexed

Erlotinib DRUG

Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days.

Also known as: Tarceva

Bevacizumab, Erlotinib, Pemetrexed

Pemetrexed DRUG

Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

Also known as: Alimta

Bevacizumab, Erlotinib, Pemetrexed

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffiitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Erlotinib Hydrochloride; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Limitations and Caveats

This study was closed early due to poor accrual. The recommended Phase II dose was determined after the brief Phase I run-in, but the Phase II component of this study was never initiated.

Results Point of Contact

• Title: George Simon, M.D.
• Organization: Fox Chase Cancer Center (formerly at H. Lee Moffitt Cancer Center & Research Institute)

george.simon@fccc.edu

215-728-2509

Study Officials

• George Simon, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 23, 2017
• Results First Posted: August 30, 2010

Record last verified: 2010-08

Locations

US (1)