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AzTrials

Lung CancerPhase 2NCT00456261

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

A Phase 2 study testing Pemetrexed, Gemcitabine and Bevacizumab in people with Lung Cancer, run by SCRI Development Innovations, LLC at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Pemetrexed, Gemcitabine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
18 sitesUnited States
Study dates
Mar 2007to Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Associates in Hematology Oncology

    Chattanooga, Tennessee, 37404

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Mercy Hospital

    Portland, Maine, 04101

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Pemetrexed/Gemcitabine/Bevacizumab or Pemetrexed/Carboplatin/Bevacizumab in the First-Line Treatment of Elderly Patients With Advanced Non-Small Cell Lung Cancer

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.

Read the detailed description

Patients in this study will be assigned to one of 2 treatment groups. The selection of the treatment groups will be done randomly by a computer.

The first group, Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.

The second group, Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.

In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the occurrence of side effects from the treatment.

Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see how well the cancer is responding to the treatment.

Conditions
Lung Cancer
Keywords
Non Small Cell Lung Cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Also called Alimta

    pemetrexed 500 mg/m2

  • GemcitabineDrug

    Also called Gemzar

    gemcitabine 1500 mg/m2

  • BevacizumabDrug

    Also called Avastin

    bevacizumab 10mg/kg bevacizumab 15mg/kg

  • CarboplatinDrug

    Also called Paraplatin

    carboplatin AUC=5

Study groups in NCT00456261
Study groupRoleWhat they receive
Cohort AExperimentalCohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
Receives: Drug: Pemetrexed; Drug: Gemcitabine; Drug: Bevacizumab
Cohort BExperimentalCohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
Receives: Drug: Pemetrexed; Drug: Bevacizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

    Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.

    Measured: From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months

Secondary outcomes (2)

  1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

    Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)

    Measured: From date of treatment initiation to end of study treatment up to 18 months

  2. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    OS is defined as the time from the date of study entry until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to the last date the participant was known to be alive.

    Measured: From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2010
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00456261
Sponsor's protocol ID
SCRI LUN 139
Status last verified
Apr 2022
First submitted
3 Apr 2007
Last updated
3 May 2022
Data monitoring committee
No

Publications

  • Spigel DR, Hainsworth JD, Shipley DL, Ervin TJ, Kohler PC, Lubiner ET, Peyton JD, Waterhouse DM, Burris HA 3rd, Greco FA. A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):196-202. doi: 10.1097/JTO.0b013e3182307efe.

    PubMed 21900836

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed, Gemcitabine and Bevacizumab in people with Lung Cancer, run by SCRI Development Innovations, LLC at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease (time frame: From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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