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| Sponsored by: |
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: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer |
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (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: | University of Iowa ( Raymond Hohl, MD ) |
| Study ID Numbers: | 200305074 |
| Study First Received: | December 21, 2007 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00585052 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Ovarian Cancer Epithelial Ovarian Cancer Lovastatin Paclitaxel |
|
Antimetabolites Ovarian Neoplasms Gonadal Disorders Antilipemic Agents Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Anticholesteremic Agents Ovarian Diseases |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Ovarian Epithelial Cancer Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Antineoplastic Agents, Phytogenic Lovastatin Endocrine Gland Neoplasms |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Lovastatin Endocrine Gland Neoplasms Ovarian Neoplasms Antilipemic Agents |
Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Anticholesteremic Agents Antimitotic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Adnexal Diseases Neoplasms Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic |