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CompletedPhase 2NCT00456261
Official study title

First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC

Study summary

This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPemetrexed and Gemcitabine

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 3, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?SCRI Development Innovations, LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SCRI Development Innovations, LLC
Interventions being studied
Drug: Pemetrexed; Drug: Gemcitabine; Drug: Bevacizumab; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or large cell carcinoma)
  • Patients who have newly diagnosed unresectable stage III or stage IV disease are eligible.
  • Must be at least 70 years of age
  • Must have measurable disease by CT scan
  • Must be able to be up and about and care for themselves
  • May not have received prior treatment for stage III or IV disease
  • Must have adequate white and red blood cells and platelets.
  • Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study
  • Must be able to understand the nature of this study and give written informed consent
  • Adequate liver and kidney function
Reasons someone may not be able to joinExclusion criteria
  • Past or current history of cancer with the exception of treated non- melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and have been disease free for five years
  • Female patients who are pregnant or are lactating are ineligible
  • History of unstable angina or myocardial infarction within 6 months prior to beginning bevacizumab
  • Brain metastasis - cancer that has spread to the brain
  • Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study
  • Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within 10 days of starting treatment
  • Serious nonhealing wound, ulcer, or bone fracture
  • Bleeding or clotting disorders
  • Uncontrolled high blood pressure or serious heart arrhythmia requiring medication
  • History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to beginning bevacizumab
  • Chronic non-steroidal anti-inflammatory use is not allowed on study
  • History of stroke or TIAs within the last 6 months Please Note: There are additional inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • NEA Baptist ClinicJonesboro, Arkansas
  • Florida Cancer SpecialistsFort Myers, Florida
  • Watson Clinic Center for Cancer Care and ResearchLakeland, Florida
  • Northeast Georgia Medical CenterGainesville, Georgia
  • Wellstar Cancer ResearchMarietta, Georgia
  • Providence Medical GroupTerre Haute, Indiana
  • Graves-Gilbert ClinicBowling Green, Kentucky
  • Consultants in Blood Disorders and CancerLouisville, Kentucky
  • Mercy HospitalPortland, Maine
  • Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan
  • Methodist Cancer CenterOmaha, Nebraska

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 3, 2022. Always confirm current availability with the study team.

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