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Non-Small Cell Lung CancerPhase 2NCT00517595

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

A Phase 2 study testing Pemetrexed and Gemcitabine plus Bevacizumab in people with Non-Small Cell Lung Cancer, run by Accelerated Community Oncology Research Network at 10 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

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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Pemetrexed and Gemcitabine plus Bevacizumab
Type of treatment
Injection or infusion
How many people
48 participants
Where
10 sitesUnited States
Study dates
Aug 2007to Apr 2011
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Significant vascular disease (aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis.)
  • Symptomatic peripheral vascular disease
  • Known bleeding diathesis or coagulopathy
  • Presence of CNS(central nervous system) except for treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging(MRI or CT)during the screening period.Anticonvulsants(stable dose)are allowed.Treatment for brain metastases may include whole brain radiotherapy(WBRT),radiosurgery(RS;Gamma Knife,LINAC,or equivalent)or a combination as deemed appropriate by the treating physician.Radiotherapy must be completed at least 4 weeks prior to study enrollment and all acute radiotherapy toxicities resolved.Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study.
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment.
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
  • Have received radiotherapy to more than 25% of their bone marrow.
  • Receiving concurrent investigational therapy or has received investigational therapy within 30 days of the first scheduled day of protocol treatment
  • Pregnant/lactating.
  • Any other medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate/participate in the study, or interfere with interpretation of the results.
  • History of allogeneic transplant.
  • Known HIV infection or Hepatitis B or C.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • Hematology Oncology Centers of the Northern Rockies

    Billings, Montana, 59101

  • Tri-County Oncology Hematology Associates

    Canton, Ohio, 44718

  • Cancer Specialists of Tidewater

    Chesapeake, Virginia, 23320

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Northwest Georgia Oncology Center

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Pacific Oncology, PC

    Portland, Oregon, 97225

  • Medical Oncology & Hematology

    Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

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.

Being tested
Pemetrexed and Gemcitabine plus Bevacizumab
Keywords
Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Pemetrexed and Gemcitabine plus BevacizumabDrug

    Also called Pemetrexed/Alimta, Gemcitabine/Gemzar, Bevacizumab/Avastin

    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.

What is being measured

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

  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.

    Measured: 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)

  1. Time to Progression (TTP)

    Time to progression is defined as the time from treatment start until objective tumor progression. 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 time to progression is the parameter used to describe TTP.

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

  2. Overall Survival (OS)

    Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.

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

  3. Overall Response

    Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.

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

Timeline

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

  1. First posted17 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2011
  4. Study completionApr 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00517595
Sponsor's protocol ID
ALJBNSCLC0602
Status last verified
Mar 2012
First submitted
16 Aug 2007
Last updated
12 Mar 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Gemcitabine plus Bevacizumab in people with Non-Small Cell Lung Cancer, run by Accelerated Community Oncology Research Network at 10 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 11 inclusion and 28 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 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 8 Mar 2012). 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?

Progression Free Survival (PFS) (time frame: 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.). 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 NCT00517595.

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 12 Mar 2012.

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