Sunitinib Non Small Cell Lung Cancer Patients Over 70
This study is ongoing, but not recruiting participants.
Sponsor:
US Oncology Research
Collaborator:
Pfizer
Information provided by:
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00864721
First received: March 18, 2009
Last updated: June 6, 2011
Last verified: June 2011
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Purpose
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Sutent |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70 |
Resource links provided by NLM:
Further study details as provided by US Oncology Research:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 63 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864721
Locations
| United States, Florida | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34471 | |
| Cancer Centers of Florida, P.A. | |
| Ocoee, Florida, United States, 34761 | |
| United States, Minnesota | |
| Minnesota Oncology Hematology, P.A. | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, North Carolina | |
| Cancer Centers of North Carolina | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Oregon | |
| Willamette Valley Cancer Institute and Research Center | |
| Eugene, Oregon, United States, 97401-8122 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Texas Oncology - Arlington South | |
| Arlington, Texas, United States, 76014 | |
| Texas Oncology, P.A. - Bedford | |
| Bedford, Texas, United States, 76022 | |
| Methodist Charlton Cancer Ctr. | |
| Dallas, Texas, United States, 75237 | |
| Texas Cancer Center of Mesquite | |
| Mesquite, Texas, United States, 75150 | |
| Texas Oncology Cancer Care and Research Center | |
| Waco, Texas, United States, 76712 | |
| United States, Virginia | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Yakima Valley Mem Hosp/North Star Lodge | |
| Yakima, Washington, United States, 98902 | |
Sponsors and Collaborators
US Oncology Research
Pfizer
More Information
No publications provided
| Responsible Party: | Regulatory Specialist, US Oncology Research, Inc. |
| ClinicalTrials.gov Identifier: | NCT00864721 History of Changes |
| Other Study ID Numbers: | 06-135 |
| Study First Received: | March 18, 2009 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by US Oncology Research:
|
Untreated NSCLC in patients > 70 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013