Sunitinib Non Small Cell Lung Cancer Patients Over 70

NCT00864721

Last updated date
Study Location
Ocala Oncology Center
Ocala, Florida, 34471, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib Non Small Cell Lung Cancer Patients Over 70
Official Title  ICMJE Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2009)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00864721
Other Study ID Numbers  ICMJE 06-135
GA6181UU ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party US Oncology Research
Study Sponsor  ICMJE US Oncology Research
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Craig H. Reynolds, MDUS Oncology Research, LLC; Ocala Oncology Center
PRS Account US Oncology Research
Verification Date October 2018

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