|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075400 |
Purpose
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent or persistent uterine carcinosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Evaluation Of Gleevec™ (NCI-Supplied Agent: STI571 [Imatinib Mesylate], IND #61135, NSC #716051) In The Treatment Of Recurrent Or Persistent Carcinosarcoma Of The Uterus |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 15-30 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed uterine carcinosarcoma
Presence of at least 1 target lesion (to be used to assess response)
Received 1 prior chemotherapy regimen for carcinosarcoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 62 Study Locations| Study Chair: | Warner Huh, MD | University of Alabama at Birmingham |
More Information
| Study ID Numbers: | CDR0000346361, GOG-0230C |
| Study First Received: | January 9, 2004 |
| Last Updated: | May 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075400 History of Changes |
| Health Authority: | United States: Federal Government |
|
uterine carcinosarcoma recurrent uterine sarcoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Imatinib |
Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Complex and Mixed Carcinosarcoma |