Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC

NCT00517595 | Completed Phase 2 Results

• 1 other identifier: ALJBNSCLC0602
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.

  PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.

Secondary Outcomes (3)

• Time to Progression (TTP)

  TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.

• Overall Survival (OS)

  OS was measured from day 1 of treatment until time of death, assessed up to 20 months.

• Overall Response

  Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.

Other Outcomes (2)

• Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

  PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.

• Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

  OS was measured from day 1 of treatment until time of death, assessed up to 20 months.

Interventions

Pemetrexed and Gemcitabine plus Bevacizumab DRUG

Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.

Also known as: Pemetrexed/Alimta, Gemcitabine/Gemzar, Bevacizumab/Avastin

Eligibility Criteria

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

You may qualify if:

• Patient provides voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
• Patient ≥ 65 years of age with ECOG of 0 to 1
• Patient must have histologically/cytologically confirmed Stage IIIB/IV NSCLC.
• Patient has measurable disease defined as at least 1 lesion that can be accurately measured in at least 1 dimension (by CT or MRI) \& used to assess response as defined by RECIST criteria. Tumors within a previously irradiated field will be designated nontarget lesions.
• Patient has not received radiotherapy within 2 weeks(4 weeks required for brain metastases radiotherapy)of initial chemotherapy dosing for this study, and all acute toxicities due to prior radiotherapy have resolved prior to initial chemotherapy dosing.
• Patient has a negative serum pregnancy test or has undergone hysterectomy at time of enrollment.
• Greater than 12 weeks life expectancy.
• Patient has recovered from any recent surgery for at least 30 days \& is free of active infection requiring antibiotics.
• Patient must be willing/able to discontinue use of NSAIDS prior to study drug dosing.
• Patient must be able to take folic acid, Vitamin B12, \& dexamethasone per protocol.
• Patient must exhibit no greater than Grade 1 peripheral neuropathy.

You may not qualify if:

• Prior systemic or other concurrent chemo for metastatic NSCLC(Prior Tarceva is not allowed).Prior adjuvant chemo acceptable as long as \> 12 months since completion and no prior pemetrexed, gemcitabine or bevacizumab.
• Lung carcinoma of squamous cell histology(mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable.Patients with extrathoracic-only squamous cell NSCLC are eligible.Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible(a peripheral lesion is defined as a lesion in which the epicenter of the tumor is ≤ 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is \> 2 cm from the trachea, main, and lobar bronchi).
• Hemoptysis within 1 month prior to study enrollment
• Ongoing treatment with full-dose warfarin or its equivalent i.e., unfractionated and/or low molecular weight heparin.(Low dose warfarin 1 mg given for prophylaxis is allowed).
• Hypersensitivity to any component of Alimta, gemcitabine \&/or bevacizumab, \&/or cannot tolerate folic acid, corticosteroids or Vitamin B12 supplements.
• Currently/have recently taken long-acting NSAID (Ibuprofen ≤ 400 mg QID acceptable) or aspirin (\>325mg/day) within 5 days of initial pemetrexed administration.
• Clinically significant pericardial/pleural effusion or ascites unless able to be drained before study entry.
• Presence of third space fluid which cannot be controlled by drainage.
• Core biopsy/other minor surgical procedure(excluding placement of a vascular access device)within 7 days prior to study enrollment.
• Active infection or fever ≥ 38.5°C within 3 days of first scheduled day of protocol treatment.
• Serious, non-healing wound, ulcer, or untreated bone fracture.
• NYHA Grade II or greater CHF
• Inadequately controlled hypertension (defined as systolic blood pressure \> 150 \&/or diastolic blood pressure \> 100mmHg on antihypertensive meds)
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• History of MI, CVA, TIA, or unstable angina within 6 months of study enrollment.

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead
• Eli Lilly and Company: collaborator
• Genentech, Inc.: collaborator

Study Sites (10)

Medical Oncology & Hematology

Waterbury, Connecticut, 06708, United States

Location

Augusta Oncology Associates

Augusta, Georgia, 30901, United States

Location

Central Georgia Cancer Care

Macon, Georgia, 31201, United States

Location

Northwest Georgia Oncology Center

Marietta, Georgia, 30060, United States

Location

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, 59101, United States

Location

Tri-County Oncology Hematology Associates

Canton, Ohio, 44718, United States

Location

Pacific Oncology, PC

Portland, Oregon, 97225, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Cancer Specialists of Tidewater

Chesapeake, Virginia, 23320, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Gemcitabine; Bevacizumab

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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Vice President of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

901-435-5570

Study Officials

• Johnetta L Blakely, MD

  Accelerated Community Oncology Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 12, 2012
• Results First Posted: March 8, 2012

Record last verified: 2012-03

Locations

US (10)