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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Patrick Joseph Loehrer Sr., Indiana University School of Medicine Identifier:
First received: September 12, 2005
Last updated: May 4, 2015
Last verified: May 2015
To study the efficacy of Alimta as a single agent in thymic cancers

Condition Intervention Phase
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:
  • to determine the objective response rate of premetrexed in previously treated patients with thymoma or thymic carcinoma. [ Time Frame: baseline, after 2 cycles, then q 6wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of remission of patients with thymoma and thymic carcinoma treated with premetrexed. To determine the toxicity of premetrexed in this patient population. [ Time Frame: baseline, after 2 cycles, then q 6wks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2005
Estimated Study Completion Date: July 2016
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00198133

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

No publications provided

Responsible Party: Patrick Joseph Loehrer Sr., Professor of Medicine, Indiana University School of Medicine Identifier: NCT00198133     History of Changes
Other Study ID Numbers: 0412-18; IUCRO-0088, IUCRO-0088
Study First Received: September 12, 2005
Last Updated: May 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Thymic Carcinoma

Additional relevant MeSH terms:
Thymus Neoplasms
Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015