ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
- 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
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Sunitinib Non Small Cell Lung Cancer Patients Over 70 | |||
Official Title ICMJE | Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70 | |||
Brief Summary | The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Non Small Cell Lung Cancer | |||
Intervention ICMJE | Drug: Sutent
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. Other Name: sunitinib malate | |||
Study Arms ICMJE | Experimental: 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. Intervention: Drug: Sutent | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 63 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2012 | |||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 70 Years and older (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00864721 | |||
Other Study ID Numbers ICMJE | 06-135 GA6181UU ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | US Oncology Research | |||
Study Sponsor ICMJE | US Oncology Research | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | US Oncology Research | |||
Verification Date | October 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |