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Home > "C" Clinical Trials Conditions > Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma  Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma
Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma
For Condition: recurrent thymoma and thymic carcinoma,invasive thymoma and thymic carcinoma
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
Details: 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 IV 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 are 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 will be accrued for this study within 3.8-4.6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500 cells/mm^3 - Platelet count at least 100,000 cells/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Other: - No acute concurrent complications such as infection or post-surgical complications - No other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for metastatic disease - Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year Endocrine therapy: - Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed Radiotherapy: - See Disease Characteristics - No concurrent local radiotherapy for pain control or life threatening situations Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickLoehrer, Study Chair, Indiana University Cancer Center
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Additional Information:
Study ID Numbers: CDR0000068461; NCI-E1C99,ECOG-1C99
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010257
Other Invasive Thymoma And Thymic Carcinoma Studies:
1. Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma
Related Studies:
Other invasive thymoma and thymic carcinoma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma
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