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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Joseph Loehrer Sr., Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT00198133
First received: September 12, 2005
Last updated: December 16, 2015
Last verified: December 2015
  Purpose
To study the efficacy of Alimta as a single agent in thymic cancers

Condition Intervention Phase
Thymoma
Thymic Carcinoma
Drug: Premetrexed (Alimta)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Objective Response Rate (Complete and Partial Response) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time from the date of remission until progression or death, assessed up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 27
Study Start Date: January 2005
Study Completion Date: May 2012
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed
Pemetrexed infusion once every 21 days (one cycle).
Drug: Premetrexed (Alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198133

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Patrick Joseph Loehrer Sr.
Investigators
Principal Investigator: Patrick Loehrer, M.D. Indiana University
  More Information

Responsible Party: Patrick Joseph Loehrer Sr., Professor of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00198133     History of Changes
Other Study ID Numbers: 0412-18; IUCRO-0088  IUCRO-0088 
Study First Received: September 12, 2005
Results First Received: December 16, 2015
Last Updated: December 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Thymoma
Thymic Carcinoma

Additional relevant MeSH terms:
Carcinoma
Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016