Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
OBJECTIVES:
- Determine the objective response rate in patients with advanced thymoma or thymic
carcinoma treated with carboplatin and paclitaxel.
- Determine the duration of response in these patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in
the absence of disease progression. Patients achieving complete or partial remission or
stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further
treatment may be given at the discretion of the treating physician.
Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within
3.8-4.6 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Overall Response by RECIST Criteria (Version 1.0)
Number of eligible, treated participants in each response category by RECIST criteria
Assessed every 2 cycles (6 weeks)
No
Patrick J. Loehrer, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
CDR0000068461
NCT00010257
February 2001
August 2012
Name | Location |
---|---|
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Froedtert Hospital and Medical College of Wisconsin | Milwaukee, Wisconsin 53226-3596 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Riddle Memorial Hospital Cancer Center | Media, Pennsylvania 19063 |
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center | Upland, Pennsylvania 19013 |