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Sponsored by: |
Cell Therapeutics |
Information provided by: | Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT00069901 |
The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.
Condition | Intervention | Phase |
Ovarian Neoplasm |
Drug: CT-2103 (poly(L)glutamate-paclitaxel) Drug: carboplatin |
Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
Drug Information available for: | Carboplatin Paclitaxel Paclitaxel Poliglumex Glutamic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study |
Enrollment: | 82 |
Study Start Date: | February 2003 |
Study Completion Date: | September 2006 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion:
United States, California | |||||
Gynecology Oncology Associates | |||||
Greenbrae, California, United States | |||||
California Cancer Care | |||||
Greenbrae, California, United States, 94904 | |||||
Stockton Hematology Oncology Medical | |||||
Stockton, California, United States, 95204 | |||||
United States, Florida | |||||
Raben and Fldman Research Associates | |||||
South Miami, Florida, United States, 33143 | |||||
United States, Kentucky | |||||
University of Louisville | |||||
Louisville, Kentucky, United States, 40202 | |||||
United States, Missouri | |||||
Resource Center for Gynecology/ Oncology | |||||
Kansas City, Missouri, United States, 64132 | |||||
United States, New York | |||||
Upstate New York Cancer Research and Education Foundation | |||||
Rochester, New York, United States, 98104 | |||||
United States, Ohio | |||||
Gynecology, Oncology, and Pelvic Surgery Associates, Inc. | |||||
Columbus, Ohio, United States, 43222 | |||||
United States, Pennsylvania | |||||
Guthrie Foundation for Education and Research | |||||
Sayre, Pennsylvania, United States, 18840 | |||||
Albert Einstein Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19141 | |||||
United States, South Carolina | |||||
South Carolina Oncology Assoicates | |||||
Columbia, South Carolina, United States, 29203 | |||||
United States, Tennessee | |||||
Baptist Regional Cancer Center | |||||
Knoxville, Tennessee, United States, 37920 | |||||
Chattanooga GYN-Oncology | |||||
Chattanooga, Tennessee, United States, 37403 | |||||
United States, Virginia | |||||
Arlington Fairfax Hematology Oncology | |||||
Arlington, Virginia, United States, 22205 | |||||
United States, Washington | |||||
Pacific Gynecology Specialists | |||||
Seattle, Washington, United States, 98104 | |||||
Swedish Cancer Institute | |||||
Seattle, Washington, United States, 98104 | |||||
United States, Wisconsin | |||||
Aurora Health Care, Inc. | |||||
Milwaukee, Wisconsin, United States, 53201 |
Cell Therapeutics |
Study Director: | Scott Stromatt, M.D. | Cell Therapeutics |
Study ID Numbers: | PGT201 |
First Received: | October 2, 2003 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00069901 |
Health Authority: | United States: Food and Drug Administration |
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