Know Cancer

or
forgot password

Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Thymoma, Thymic Carcinoma

Thank you

Trial Information

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.


Inclusion Criteria:



- Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic
carcinoma not amenable to potentially curative therapy by surgery

- 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:

- Acute concurrent complications such as infection or post-surgical complications

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Response by RECIST Criteria (Version 1.0)

Outcome Description:

Number of eligible, treated participants in each response category by RECIST criteria

Outcome Time Frame:

Assessed every 2 cycles (6 weeks)

Safety Issue:

No

Principal Investigator

Patrick J. Loehrer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068461

NCT ID:

NCT00010257

Start Date:

February 2001

Completion Date:

August 2012

Related Keywords:

  • Thymoma
  • Thymic Carcinoma
  • thymoma
  • thymic carcinoma
  • Carcinoma
  • Thymoma

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Froedtert Hospital and Medical College of WisconsinMilwaukee, Wisconsin  53226-3596
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Rapid City Regional HospitalRapid City, South Dakota  57709
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Riddle Memorial Hospital Cancer CenterMedia, Pennsylvania  19063
Associates in Hematology-Oncology, PC at Crozer Regional Cancer CenterUpland, Pennsylvania  19013