Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00198133

Purpose

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

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

MedlinePlus related topics: Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

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 2008

Intervention Details:

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
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

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

Indiana University School of Medicine

Investigators

Principal Investigator:

Patrick Loehrer, M.D.

Indiana University

More Information

Responsible Party:	Indiana University Cancer Center ( Patrick Loehrer, MD/ Principal Investigator )
Study ID Numbers:	0412-18, IUCRO-0088
Study First Received:	September 12, 2005
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00198133
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Thymoma
Thymic Carcinoma

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Thymoma

Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 15, 2009