|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | US Oncology Research |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT00864721 |
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 II |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| 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 |
|
Untreated NSCLC in patients > 70 |
|
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 |