Thymic Carcinoma, Thymoma
Conditions
Keywords
thymoma, thymic carcinoma
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.
Interventions
DRUGcarboplatin
Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
DRUGpaclitaxel
225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
The study was activated on February 21, 2001 and accrued its first patient on June 19, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Thymoma Patients with diagnosis of thymoma | 25 |
| Thymic Carcinoma Patients with diagnosis of thymic carcinoma | 21 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Thymoma | Thymic Carcinoma | Total |
|---|---|---|---|
| Age, Continuous | 50.8 Years | 49.2 Years | 50.7 Years |
| Region of Enrollment United States | 25 participants | 21 participants | 46 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 24 | 21 / 21 |
| serious Total, serious adverse events | 13 / 24 | 14 / 21 |
Outcome results
Primary
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)
Population: Analysis population included all eligible participants who received at least 1 dose of the protocol treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thymoma | Best Overall Response by RECIST Criteria (Version 1.0) | Partial Response | 5 Participants |
| Thymoma | Best Overall Response by RECIST Criteria (Version 1.0) | Progression | 0 Participants |
| Thymoma | Best Overall Response by RECIST Criteria (Version 1.0) | Stable Disease | 13 Participants |
| Thymoma | Best Overall Response by RECIST Criteria (Version 1.0) | Unevaluable | 2 Participants |
| Thymoma | Best Overall Response by RECIST Criteria (Version 1.0) | Complete Response | 3 Participants |
| Thymic Carcinoma | Best Overall Response by RECIST Criteria (Version 1.0) | Unevaluable | 2 Participants |
| Thymic Carcinoma | Best Overall Response by RECIST Criteria (Version 1.0) | Complete Response | 0 Participants |
| Thymic Carcinoma | Best Overall Response by RECIST Criteria (Version 1.0) | Partial Response | 6 Participants |
| Thymic Carcinoma | Best Overall Response by RECIST Criteria (Version 1.0) | Stable Disease | 8 Participants |
| Thymic Carcinoma | Best Overall Response by RECIST Criteria (Version 1.0) | Progression | 4 Participants |
Secondary
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
Population: Number of participants achieving a complete or partial response by RECIST criteria
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thymoma | Duration of Response | 16.9 Months |
| Thymic Carcinoma | Duration of Response | 5.0 Months |