Back to resultsPhase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Primary Purpose
Thymoma, Thymic Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Premetrexed (Alimta)
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma focused on measuring Thymoma, Thymic Carcinoma
Eligibility Criteria
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
Sites / Locations
- Indiana University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed
Arm Description
Pemetrexed infusion once every 21 days (one cycle).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT00198133
First Posted
September 12, 2005
Last Updated
July 8, 2019
Sponsor
Patrick Joseph Loehrer Sr.
1. Study Identification
Unique Protocol Identification Number
NCT00198133
Brief Title
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Official Title
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Joseph Loehrer Sr.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Thymic Carcinoma
Keywords
Thymoma, Thymic Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed
Arm Type
Experimental
Arm Description
Pemetrexed infusion once every 21 days (one cycle).
Intervention Type
Drug
Intervention Name(s)
Premetrexed (Alimta)
Intervention Description
Pemetrexed will be 500 mg/m2 IV every 3 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate (Complete and Partial Response)
Description
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
Secondary Outcome Measure Information:
Title
Duration of Remission
Description
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
Title
Grade 3/4 Treatment Related Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Loehrer, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30121390
Citation
Gbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16.
Results Reference
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Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
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