AzTrials
AzTrials

Non Small Cell Lung CancerPhase 2NCT00864721

Sunitinib Non Small Cell Lung Cancer Patients Over 70

A Phase 2 study testing Sutent in people with Non Small Cell Lung Cancer, run by US Oncology Research at 13 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Sutent
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
13 sitesUnited States
Study dates
Feb 2009to Jul 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

  • Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" patients enrollment in the study must be approved by Dr. Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous histology to be eligible for this study.
  • Has not received any prior chemotherapy for the current disease.
  • Has an ECOG Performance status. Is 70 years of age or older.Has resolution of all acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.
  • If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to avoid pregnancy for the duration of the study and for a period of 2 months thereafter.
  • Has signed the most recent Patient Informed Consent Form. Has signed a Pate int Authorization Form.

Who cannot join

  • Has predominantly squamous NSCLC histology.
  • Had prior treatment with study drugs or other drugs.
  • Has a history of hypersensitivity to any component of the study drug. Has any evidence of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or clotting diathesis.
  • Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement of blood vessels.
  • Has had major surgery or radiation therapy within 4 weeks of starting the study treatment.
  • Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment.
Show all 17Show fewer
  • Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan; however, treated, stable, and asymptomatic brain metastases are allowed.
  • Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2.
  • Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.
  • Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
  • Is receiving concurrent treatment on another clinical trial.
  • Supportive care trials or non-treatment trials, (eg, QOL), are allowed.
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 days.
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
  • Is unable to comply with requirements of study

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Texas Oncology - Arlington South

    Arlington, Texas, 76014

  • Texas Oncology, P.A. - Bedford

    Bedford, Texas, 76022

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401-8122

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70

The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.

Read the detailed description

In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.

Being tested
Sutent
Keywords
Untreated NSCLC in patients > 70
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.

  • SutentDrug

    Also called sunitinib malate

    Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.

Study groups in NCT00864721
Study groupRoleWhat they receive
Sunitinib MalateExperimentalSunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Receives: Drug: Sutent

What is being measured

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

  1. Disease Control Rate (DCR)

    Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

    Measured: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.

Secondary outcomes (4)

  1. Overall Response Rates (OR)

    Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Every 6 weeks until progressive disease or death due to any causes, up to 36 months.

  2. Progression-free Survival (PFS)

    PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: All patients were followed until progressive disease or death, up to 36 months.

  3. 1-year Overall Survival (OS) Rate.

    OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.

    Measured: All patients were followed until death or up to 36 months.

  4. Time to Progression (TTP)

    TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: All patients were followed until progressive disease or death, up to 36 months.

Timeline

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

  1. First posted19 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2012
  4. Study completionJul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00864721
Sponsor's protocol ID
06-135
Other IDs
GA6181UU
Status last verified
Oct 2018
First submitted
18 Mar 2009
Last updated
16 Oct 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sutent in people with Non Small Cell Lung Cancer, run by US Oncology Research at 13 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 5 inclusion and 17 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 16 Oct 2018). 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?

Disease Control Rate (DCR) (time frame: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.). 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 NCT00864721.

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 16 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in