Sunitinib Non Small Cell Lung Cancer Patients Over 70

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864721
• Other study ID #: 06-135
• Secondary ID: GA6181UU
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2018
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
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	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Texas Cancer Center of Mesquite	Mesquite	Texas
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Texas Oncology Cancer Care and Research Center	Waco	Texas
United States	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
US Oncology Research	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Secondary	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.	Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Secondary	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.	All patients were followed until progressive disease or death, up to 36 months.
Secondary	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.	All patients were followed until death or up to 36 months.
Secondary	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.	All patients were followed until progressive disease or death, up to 36 months.