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):
Indiana University ( Indiana University School of Medicine )
First received: September 12, 2005
Last updated: October 26, 2012
Last verified: October 2012
To study the efficacy of Alimta as a single agent in thymic cancers
Drug: Premetrexed (Alimta)
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||December 2006 (Final data collection date for primary outcome measure)
Pemetrexed infusion once every 21 days (one cycle).
Drug: Premetrexed (Alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks
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:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198133
|Indiana University Cancer Center
|Indianapolis, Indiana, United States, 46202 |
Indiana University School of Medicine
||Patrick Loehrer, M.D.
No publications provided
||Indiana University ( Indiana University School of Medicine )
History of Changes
|Other Study ID Numbers:
||0412-18; IUCRO-0088, IUCRO-0088
|Study First Received:
||September 12, 2005
||October 26, 2012
||United States: Institutional Review Board
Keywords provided by Indiana University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists