Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University School of Medicine
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00198133
First received: September 12, 2005
Last updated: October 26, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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 2013 |
| 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 |
| 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
No publications provided
| Responsible Party: | Indiana University ( 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 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Thymoma Thymic Carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Thymoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Thymus Neoplasms Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases |
Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013