Sunitinib Non Small Cell Lung Cancer Patients Over 70

NCT ID: NCT00864721

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-07-31

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sutent

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

sunitinib malate

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

US Oncology Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig H. Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

US Oncology Research, LLC; Ocala Oncology Center

Locations

Ocala Oncology Center

Ocala, Florida, United States

Cancer Centers of Florida, P.A.

Ocoee, Florida, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Cancer Centers of North Carolina

Raleigh, North Carolina, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Texas Oncology - Arlington South

Arlington, Texas, United States

Texas Oncology, P.A. - Bedford

Bedford, Texas, United States

Methodist Charlton Cancer Ctr.

Dallas, Texas, United States

Texas Cancer Center of Mesquite

Mesquite, Texas, United States

Texas Oncology Cancer Care and Research Center

Waco, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, United States

Countries

United States

Other Identifiers

GA6181UU

Identifier Type: OTHER

Identifier Source: secondary_id

06-135

Identifier Type: -

Identifier Source: org_study_id