|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
Novartis |
| Information provided by (Responsible Party): | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00840450 |
Purpose
This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Gleevec/Paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin |
| Enrollment: | 14 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Paclitaxel + Imatinib Mesylate (Gleevec) |
Drug: Gleevec/Paclitaxel
One treatment cycle: Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days. Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days. After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen.
*Eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease.
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| NYU cancer center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Franco M Muggia, MD | New York University School of Medicine |
More Information
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00840450 History of Changes |
| Other Study ID Numbers: | 06-226, CSTI57BUS224 |
| Study First Received: | February 9, 2009 |
| Results First Received: | August 18, 2011 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
ovarian cancer recurrent Gleevec |
Paclitaxel Taxane mullerian |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Paclitaxel |
Imatinib Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |