Trial · NCT00198133
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
NCT00198133, Phase 2, Completed, Patrick Joseph Loehrer Sr.; results first posted 2016-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma. Trials, record NCT00198133. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00198133
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
- NCT number
- NCT00198133
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Patrick Joseph Loehrer Sr.
- Conditions
- Thymoma, Thymic Carcinoma
- Interventions
- Premetrexed (Alimta)
- First posted
- 2005-09-20
- Last updated
- 2019-07-22
- Results first posted
- 2016-01-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Complete and Partial Response) | Up to 3 years | All patients with at least one post baseline measurement. (26 evaluable - 15 T and 11 TC patients) | percentage of participants | NUMBER |
| SECONDARY | Duration of Remission | Time from the date of remission until progression or death, assessed up to 3 years | All patients with at least one post baseline measurement who had a response of CR or PR | months | MEDIAN |
| SECONDARY | Grade 3/4 Treatment Related Adverse Events | Up to 3 years | All patients enrolled and received treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete and Partial Response) | Thymoma | 26.7 | 95% Confidence Interval 7.8 to 55.1 | percentage of participants | |
| Objective Response Rate (Complete and Partial Response) | Thymic Carcinoma | 9.1 | 95% Confidence Interval 0.2 to 41.3 | percentage of participants | |
| Duration of Remission | Thymoma | 4.0 | 95% Confidence Interval 3.3 to 6.3 | months | |
| Duration of Remission | Thymic Carcinoma | 3.8 | 95% Confidence Interval NA to NA | months | |
| Grade 3/4 Treatment Related Adverse Events | Thymoma | 1 | participants | ||
| Grade 3/4 Treatment Related Adverse Events | Thymic Carcinoma | 1 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thymoma | 16 | |
| Overall Study | STARTED | Thymic Carcinoma | 11 | |
| Overall Study | COMPLETED | Thymoma | 11 | |
| Overall Study | COMPLETED | Thymic Carcinoma | 3 | |
| Overall Study | NOT COMPLETED | Thymoma | 5 | |
| Overall Study | NOT COMPLETED | Thymic Carcinoma | 8 |
Source ClinicalTrials.gov
Adverse events374
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANC (NEUTROPENIA) | Blood and lymphatic system disorders | Thymoma | 1 | 16 | |
| other | ANC (NEUTROPENIA) | Blood and lymphatic system disorders | Thymic Carcinoma | 0 | 11 | |
| other | ANEMIA | Blood and lymphatic system disorders | Thymoma | 0 | 16 | |
| other | ANEMIA | Blood and lymphatic system disorders | Thymic Carcinoma | 1 | 11 | |
| other | ANKLE EDEMA | Blood and lymphatic system disorders | Thymoma | 0 | 16 | |
| other | ANKLE EDEMA | Blood and lymphatic system disorders | Thymic Carcinoma | 2 | 11 | |
| other | BILATERAL ANKLE EDEMA | Blood and lymphatic system disorders | Thymoma | 1 | 16 | |
| other | BILATERAL ANKLE EDEMA | Blood and lymphatic system disorders | Thymic Carcinoma | 0 | 11 | |
| other | EDEMA +1 | Blood and lymphatic system disorders | Thymoma | 0 | 16 | |
| other | EDEMA +1 | Blood and lymphatic system disorders | Thymic Carcinoma | 1 | 11 |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thymoma | ||
| Total, all-cause mortality | Thymic Carcinoma | ||
| Total, other adverse events | Thymoma | 16 | 16 |
| Total, other adverse events | Thymic Carcinoma | 11 | 11 |
| Total, serious adverse events | Thymoma | 2 | 16 |
| Total, serious adverse events | Thymic Carcinoma | 3 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30121390 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thymoma vs Thymic Carcinoma: Grade 3/4 Treatment Related Adverse Events | Trial comparisons |
| Thymoma vs Thymic Carcinoma: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00198133
GET https://conductscience.org/api/trials/v1/NCT00198133/events?page=2