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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Millennium Pharmaceuticals |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00059618 |
Purpose
The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.
| Condition | Intervention | Phase |
|
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer |
Drug: PS-341 (Bortezomib) Drug: Carboplatin |
Phase I |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | Carboplatin Bortezomib |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer |
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2003 |
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Platinum resistance is defined as:
Adequate liver, renal and bone marrow function, defined as:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |||||
| University of Texas M. D. Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Millennium Pharmaceuticals |
| Principal Investigator: | Pedro T. Ramirez, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | ID02-114 |
| First Received: | April 29, 2003 |
| Last Updated: | May 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00059618 |
| Health Authority: | United States: Food and Drug Administration |
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