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Study 7 of 594 for search of: | received on or after 01/16/2009 |
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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) National Comprehensive Cancer Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00825201 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: liquid chromatography Procedure: mass spectrometry Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity |
Estimated Enrollment: | 20 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Plasma and peritoneal fluid samples are collected periodically for pharmacokinetic analysis by liquid chromatography and mass spectometry.
After completion of study treatment, patients are followed for 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced cancer primarily confined to the peritoneal cavity
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Principal Investigator: | Mihaela Cristea, MD | Beckman Research Institute |
Study Chair: | Mihaela Cristea, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Mihaela Cristea ) |
Study ID Numbers: | CDR0000632797, CHNMC-08059, ABRAXIS-CHNMC-08059, NCCN-A02 |
Study First Received: | January 16, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00825201 |
Health Authority: | Unspecified |
peritoneal carcinomatosis peritoneal cavity cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer unspecified adult solid tumor, protocol specific |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Recurrence Genital Diseases, Female Digestive System Diseases Paclitaxel Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Adnexal Diseases |