Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
NCT ID: NCT00010257
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2001-06-19
2012-08-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel plus Carboplatin
Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
carboplatin
Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
paclitaxel
225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
Interventions
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carboplatin
Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
paclitaxel
225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
* Advanced limited disease allowed if ineligible for primary radiotherapy or surgery
* Measurable disease
* Age 18 and over
* ECOG Performance Status 0-1
* Granulocyte count at least 1,500 cells/mm\^3
* Platelet count at least 100,000 cells/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* Creatinine no greater than 2.0 mg/dL
* Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed
Exclusion Criteria
* Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
* Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception
* Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Patrick J. Loehrer, MD
Role: STUDY_CHAIR
Indiana University Melvin and Bren Simon Cancer Center
Locations
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Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Riddle Memorial Hospital Cancer Center
Media, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Countries
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References
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Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.
Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. doi: 10.1200/JCO.2010.32.9607. Epub 2011 Apr 18.
Other Identifiers
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E1C99
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068461
Identifier Type: -
Identifier Source: org_study_id
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