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| Sponsor: | University of Iowa |
|---|---|
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00585052 |
Purpose
The purpose of this study is to find out if the treatment combination of paclitaxel and lovastatin is more effective than the currently available chemotherapy for refractory or relapsed ovarian cancer. This research is being done to improve on currently available chemotherapy for ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Lovastatin and Paclitaxel |
Phase II |
| 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: | A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer |
| Estimated Enrollment: | 16 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
The main goal of the study is to find out if adding lovastatin to paclitaxel increases the number of people whose tumors shrink or whose disease responds to the treatment. Another purpose of the study is to find out how long tumors stay reduced in size before growing again as well as how long people live after receiving paclitaxel and lovastatin. The study will also gather information on the side effects, if any, of this combination of paclitaxel and lovastatin.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Raymond Hohl, MD | 319-356-8110 | raymond-hohl@uiowa.edu |
| Contact: Pamela Zehr, RN | 319-353-8914 | pamela-zehr@uiowa.edu |
| United States, Iowa | |
| Holden Comprehensive Cancer Center | Recruiting |
| Iowa City, Iowa, United States, 52327 | |
| Contact: Raymond Hohl, MD 319-356-8110 raymond-hohl@uiowa.edu | |
| Contact: Pamela Zehr, RN 319-353-8914 pamela-zehr@uiowa.edu | |
| Principal Investigator: | Raymond Hohl, MD | University of Iowa |
More Information
| Responsible Party: | Raymond Hohl, MD, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00585052 History of Changes |
| Other Study ID Numbers: | 200305074 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 20, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Ovarian Cancer Epithelial Ovarian Cancer Lovastatin Paclitaxel |
|
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 Lovastatin Paclitaxel Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Antineoplastic Agents |