Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

Eastern Cooperative Oncology Group46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thymoma Thymic Carcinoma

Interventions

carboplatinDRUG

Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles

paclitaxelDRUG

225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (67)

Outcomes

Primary Outcomes

Best Overall Response by RECIST Criteria (Version 1.0)

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

Time frame: Assessed every 2 cycles (6 weeks)

Secondary Outcomes

Duration of Response

Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria

Time frame: assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 57 more locations