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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Millennium Pharmaceuticals, Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00059618 |
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 |
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Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer |
Drug: PS-341 (Bortezomib) Drug: Carboplatin |
Phase I |
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 |
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:
United States, Texas | |
University of Texas M. D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Pedro T. Ramirez, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | ID02-114 |
Study First Received: | April 29, 2003 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00059618 |
Health Authority: | United States: Food and Drug Administration |
Platinum Resistant Taxane Resistant Ovarian Cancer Primary Peritoneal Cancer |
Fallopian Tube Cancer Bortezomib PS-341 Carboplatin |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Bortezomib Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Taxane Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Adnexal Diseases |