Thymic Carcinoma, Thymoma
Conditions
Keywords
Thymoma, Thymic Carcinoma
Brief summary
To study the efficacy of Alimta as a single agent in thymic cancers
Detailed description
The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.
Interventions
Pemetrexed will be 500 mg/m2 IV every 3 weeks
Sponsors
Patrick Joseph Loehrer Sr.
Study design
Allocation
NON_RANDOMIZED
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. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated. * Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration. * Patients may have had prior chemotherapy for metastatic disease * Adequate organ function as defined by: bili \</=1.5; calc. crt clr of \>/=45; hematologic-granulocytes \>/=1500 & plt \>/=100K. * Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible. * ECOG performance status of 0 or 1
Exclusion criteria
* Acute intercurrent infection or complications * pregnancy or lactating patients * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents. * Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (Complete and Partial Response) | Up to 3 years | The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Remission | Time from the date of remission until progression or death, assessed up to 3 years | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. |
| Grade 3/4 Treatment Related Adverse Events | Up to 3 years | To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely). |
Countries
United States
Participant flow
Recruitment details
This protocol was based on getting 27 evaluable patients through a two-stage design
Participants by arm
| Arm | Count |
|---|---|
| Thymoma Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks | 16 |
| Thymic Carcinoma Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks | 11 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Disease progression | 2 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Thymic Carcinoma | Total | Thymoma |
|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 14.4 | 53.8 years STANDARD_DEVIATION 14 | 54.2 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 27 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 16 | 11 / 11 |
| serious Total, serious adverse events | 2 / 16 | 3 / 11 |
Outcome results
Primary
Objective Response Rate (Complete and Partial Response)
The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
Time frame: Up to 3 years
Population: All patients with at least one post baseline measurement. (26 evaluable - 15 T and 11 TC patients)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymoma | Objective Response Rate (Complete and Partial Response) | 26.7 percentage of participants |
| Thymic Carcinoma | Objective Response Rate (Complete and Partial Response) | 9.1 percentage of participants |
Secondary
Duration of Remission
Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
Time frame: Time from the date of remission until progression or death, assessed up to 3 years
Population: All patients with at least one post baseline measurement who had a response of CR or PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thymoma | Duration of Remission | 4.0 months |
| Thymic Carcinoma | Duration of Remission | 3.8 months |
Secondary
Grade 3/4 Treatment Related Adverse Events
To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).
Time frame: Up to 3 years
Population: All patients enrolled and received treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thymoma | Grade 3/4 Treatment Related Adverse Events | 1 participants |
| Thymic Carcinoma | Grade 3/4 Treatment Related Adverse Events | 1 participants |