Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Paclitaxel plus Carboplatin	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
Paclitaxel plus Carboplatin	paclitaxel	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

Primary Outcome Measures

Name	Time	Method
Best Overall Response by RECIST Criteria (Version 1.0)	Assessed every 2 cycles (6 weeks)	Number of eligible, treated participants in each response category by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Duration of Response	assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter	Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria

Locations (67): 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
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Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States