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

July 8, 2019 updated by: Patrick Joseph Loehrer Sr.
To study the efficacy of Alimta as a single agent in thymic cancers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pemetrexed
Pemetrexed infusion once every 21 days (one cycle).
Drug: Premetrexed (Alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (Complete and Partial Response)
Time Frame: 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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Remission
Time Frame: 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.
Time from the date of remission until progression or death, assessed up to 3 years
Grade 3/4 Treatment Related Adverse Events
Time Frame: 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).
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patrick Joseph Loehrer Sr.

Investigators

  • Principal Investigator: Patrick Loehrer, M.D., Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0412-18; IUCRO-0088
  • IUCRO-0088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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