Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

Phase 2

Completed

Conditions: Thymoma
Thymic Carcinoma

Interventions: Drug: carboplatin
Drug: paclitaxel

Registration Number: NCT00010257

Lead Sponsor: Eastern Cooperative Oncology Group

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

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

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

Trial Locations

Locations (67): HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸
Woodbury, Minnesota, United States
Mount Nittany Medical Center
🇺🇸
State College, Pennsylvania, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸
Joliet, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸
Sioux City, Iowa, United States
Hutchinson Area Health Care
🇺🇸
Hutchinson, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸
Saint Louis Park, Minnesota, United States
Riddle Memorial Hospital Cancer Center
🇺🇸
Media, Pennsylvania, United States
Mercy Fitzgerald Hospital
🇺🇸
Darby, Pennsylvania, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸
New Brunswick, New Jersey, United States
Albert Einstein Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
🇺🇸
Scranton, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸
Rapid City, South Dakota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
🇺🇸
Upland, Pennsylvania, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸
Sioux City, Iowa, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸
Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸
Sioux City, Iowa, United States
Borgess Medical Center
🇺🇸
Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸
Kalamazoo, Michigan, United States
Fairview Ridges Hospital
🇺🇸
Burnsville, Minnesota, United States
Fairview Southdale Hospital
🇺🇸
Edina, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸
Maplewood, 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
CCOP - Northern New Jersey
🇺🇸
Hackensack, New Jersey, United States
Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
St. Rita's Medical Center
🇺🇸
Lima, Ohio, United States
Medical X-Ray Center, PC
🇺🇸
Sioux Falls, South Dakota, United States
Avera Cancer Institute
🇺🇸
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. Vincent Hospital Regional Cancer Center
🇺🇸
Green Bay, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸
Marshfield, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸
La Crosse, Wisconsin, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸
Maplewood, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸
Robbinsdale, Minnesota, United States
Rush-Copley Cancer Care Center
🇺🇸
Aurora, Illinois, United States
Swedish-American Regional Cancer Center
🇺🇸
Rockford, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸
Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸
Cedar Rapids, Iowa, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
🇺🇸
Flemington, New Jersey, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸
Escanaba, Michigan, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸
Fridley, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸
Coon Rapids, Minnesota, United States
Bronson Methodist Hospital
🇺🇸
Kalamazoo, Michigan, United States
Dickinson County Healthcare System
🇺🇸
Iron Mountain, Michigan, United States
Meeker County Memorial Hospital
🇺🇸
Litchfield, Minnesota, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Hennepin County Medical Center - Minneapolis
🇺🇸
Minneapolis, Minnesota, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸
Marinette, Wisconsin, United States
Park Nicollet Cancer Center
🇺🇸
Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸
Woodbury, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸
Saint Paul, Minnesota, United States
Marshfield Clinic - Indianhead Center
🇺🇸
Rice Lake, Wisconsin, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸
Canton, Ohio, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸
Green Bay, Wisconsin, United States
Lewistown Hospital
🇺🇸
Lewistown, Pennsylvania, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸
Oconto Falls, Wisconsin, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸
Sturgeon Bay, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
🇺🇸
Milwaukee, Wisconsin, United States