Clinical trial NCT00864721: Sunitinib Non Small Cell Lung Cancer Patients Over 70
Official title: Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Untreated NSCLC in patients > 70
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-03-19
Enrollment: 63
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Secondary outcomes:
measure: Overall Response Rates (OR)
timeFrame: Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
measure: Progression-free Survival (PFS)
timeFrame: All patients were followed until progressive disease or death, up to 36 months.
measure: 1-year Overall Survival (OS) Rate.
timeFrame: All patients were followed until death or up to 36 months.
measure: Time to Progression (TTP)
timeFrame: All patients were followed until progressive disease or death, up to 36 months.
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Arlington
country: United States
facility: Texas Oncology - Arlington South
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A. - Bedford
state: Texas
city: Dallas
country: United States
facility: Methodist Charlton Cancer Ctr.
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care and Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Yakima
country: United States
facility: Yakima Valley Mem Hosp/North Star Lodge
state: Washington
Study officials:
affiliation: US Oncology Research, LLC; Ocala Oncology Center
name: Craig H. Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: