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):
First received: September 12, 2005
Last updated: September 18, 2014
Last verified: September 2014
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00198133
|Indiana University Cancer Center
|Indianapolis, Indiana, United States, 46202 |
||Patrick Loehrer, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
||0412-18; IUCRO-0088, IUCRO-0088
|Study First Received:
||September 12, 2005
||September 18, 2014
||United States: Institutional Review Board
Keywords provided by Indiana University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
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