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Sunitinib Non Small Cell Lung Cancer Patients Over 70

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Sutent (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Craig H. Reynolds, MD, Principal Investigator, Affiliation: US Oncology Research, LLC; Ocala Oncology Center

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary objective of the study is to evaluate efficacy, based on disease control rate (CR, PR, and SD at 6-weeks).

Secondary outcome: overall response rates,progression-free survival;time to progression,1-year survival, determining the tolerability and safety profile of sunitinib malate in this group of patients.

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.

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ocala Oncology Center, Ocala, Florida 34471, United States

Cancer Centers of Florida, P.A., Ocoee, Florida 34761, United States

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota 55404, United States

Cancer Centers of North Carolina, Raleigh, North Carolina 27607, United States

Willamette Valley Cancer Institute and Research Center, Eugene, Oregon 97401-8122, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29605, United States

Texas Oncology - Arlington South, Arlington, Texas 76014, United States

Texas Oncology, P.A. - Bedford, Bedford, Texas 76022, United States

Methodist Charlton Cancer Ctr., Dallas, Texas 75237, United States

Texas Cancer Center of Mesquite, Mesquite, Texas 75150, United States

Texas Oncology Cancer Care and Research Center, Waco, Texas 76712, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Yakima Valley Mem Hosp/North Star Lodge, Yakima, Washington 98902, United States

Additional Information

Starting date: February 2009
Last updated: May 19, 2014

Page last updated: August 23, 2015

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