Sunitinib Non Small Cell Lung Cancer Patients Over 70

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00864721
First received: March 18, 2009
Last updated: May 19, 2014
Last verified: May 2014

March 18, 2009
May 19, 2014
February 2009
July 2012   (final data collection date for primary outcome measure)
The primary objective of the study is to evaluate efficacy, based on disease control rate (CR, PR, and SD at 6-weeks). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864721 on ClinicalTrials.gov Archive Site
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. [ Time Frame: course of the trial ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sunitinib Non Small Cell Lung Cancer Patients Over 70
Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864721
06-135, GA6181UU
No
US Oncology Research
US Oncology Research
Pfizer
Principal Investigator: Craig H. Reynolds, MD US Oncology Research, LLC; Ocala Oncology Center
US Oncology Research
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP