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

Phase 2
70 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 weeks

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Untreated NSCLC in patients > 70
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Virginia Oncology Associates Newport News, Virginia  23606
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Cancer Centers of Florida, P.A. Orlando, Florida  
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Texas Oncology, P.A. - Bedford Bedford, Texas  76022
Yakima Valley Mem Hosp/North Star Lodge Yakima, Washington  98902
Texas Oncology Cancer Care and Research Center Waco, Texas  76712
Cancer Centers of North Carolina Raleigh, North Carolina  27607
Willamette Valley Cancer Institute and Research Center Springfield, Oregon  97477
Methodist Charlton Cancer Ctr. Dallas, Texas  75237
Texas Oncology - Arlington South Arlington, Texas  76014-2084