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Completed

NCT Number: NCT00198133

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

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

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Key information

Conditions

Thymoma Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymic Carcinoma Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premetrexed (Alimta)

Drug

Pemetrexed will be 500 mg/m2 IV every 3 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Patrick Joseph Loehrer Sr.

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2012
First posted
Sep 20, 2005
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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