Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Thymoma Clinical Trial

Official title:

Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198133
• Other study ID #: 0412-18; IUCRO-0088
• Secondary ID: IUCRO-0088
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: May 2012

Study information

• Verified date: July 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the efficacy of Alimta as a single agent in thymic cancers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2012
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Thymic Carcinoma
• Thymoma
• Thymus Neoplasms

Intervention

Drug:
• Premetrexed (Alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Joseph Loehrer Sr.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 3 years
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 from the date of remission until progression or death, assessed up to 3 years
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).	Up to 3 years