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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Institutes of Health (NIH) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00102622 |
The goal of this clinical research study is to find the highest safe dose of intraperitoneal tgDCC-E1A that can be given in combination with paclitaxel as a treatment for patients with recurrent, platinum-resistant ovarian cancer. How the cancer responds to this treatment will also be studied. We will also ask the patients if they will allow additional tumor samples to be collected and extra blood samples to be drawn. These samples will be used to learn about the biological response before and after treatment.
Condition | Intervention | Phase |
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Ovarian Cancer |
Biological: Intraperitoneal tgDCC-E1A Drug: Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Randomized Study of Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer |
Estimated Enrollment: | 88 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Paclitaxel + IP tgDCC-E1A
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Biological: Intraperitoneal tgDCC-E1A
Starting Dose Level: 1.8 mg DNA/m^2 intraperitoneal every 7 days +/- 2 days for a total of 6 treatments each cycle.
Drug: Paclitaxel
Arm 1: Starting dose = 80 mg/m^2 IV every 7 days +/- 2 days for a total of 6 treatments. Arm 2: Starting dose = 80 mg/m^2 IV every 7 days +/- 2 days for a total of 6 treatments. |
2: Active Comparator
Paclitaxel Alone
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Drug: Paclitaxel
Arm 1: Starting dose = 80 mg/m^2 IV every 7 days +/- 2 days for a total of 6 treatments. Arm 2: Starting dose = 80 mg/m^2 IV every 7 days +/- 2 days for a total of 6 treatments. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Previous radiation to more than 25% of marrow-bearing areas.
United States, Texas | |
University of Texas M. D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Judith Wolf, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Judith Wolf, MD/Assoc. Professor ) |
Study ID Numbers: | ID02-321, p50 CA 083639 |
Study First Received: | January 31, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00102622 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ovary ovarian cancer biologic therapy platinum-resistant platinum-refractory ovarian cancer |
platinum-resistant ovarian cancer paclitaxel tgDCC-E1A E1A Taxol |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antimitotic Agents |
Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |